Drug Injury Watch

Beovu Side Effects Have Caused Eye Doctors to Avoid Beovu and Use Other Safer AMD Drugs Instead

In Addition, the Three New Beovu Lawsuits Filed for Patients with Vision Loss May Further Impact Novartis Market Share

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Since being approved by the FDA in 2019, Beovu (brolucizumab) has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. In turn, during 2020 these Beovu side effects caused some eye doctors to avoid using Beovu injections for treatment of neovascular (wet) age-related macular degeneration (AMD). Now, at the start of 2021, Beovu lawsuits have been filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to adequately warn doctors and patients about serious Beovu side effects.

We start with a "snap-shot" of where things stood a month ago for Beovu, before the three recently filed Beovu drug injury lawsuits. From this December 15, 2020 news article, "Beovu's success in Kestrel is unlikely to fly in the real world", by reporter Lisa Urquhart for Evaluate Vantage, we get the following:

Novartis is now two for two with its pivotal trials of Beovu in diabetic macular oedema, following positive results from the Kestrel study. In the 571-patient trial a 6mg dose of the single-chain antibody fragment was non-inferior to 2mg of Regeneron/Bayer's Eylea in terms of baseline changes in best corrected visual acuity. The trial confirms the results seen in the Kite study, and also showed that Beovu could be used with a three-month dosing schedule. However, Novartis’s success here is unlikely to turn the tide on Beovu’s disappointing launch. The product, which is marketed for wet age-related macular degeneration, has been beset by serious safety concerns including severe intraocular inflammation and sight-threatening occlusive retinal vasculitis that has seen not only a revision to its label, but several class action lawsuits. Beovu’s side-effects have caused physicians to avoid the drug for safer options and sales forecasts to crash. Any chances of Novartis capturing market share are also likely to be further impacted by the patent expiry of Lucentis, expected next year, while the market is also bracing for Eylea biosimilars in 2024.

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A possible indication of the Novartis strategy for battling back from this less-than-ideal current posture can be found in a "Novartis Fourth Quarter and Full Year 2020 Condensed financial report – Supplementary Data" document:

Post marketing cases termed as “intraocular inflammation.” and/or “retinal vascular occlusion” that may result in severe vision loss, typically associated with intraocular inflammation and the current COVID-19 situation had an unfavorable impact on sales. Novartis has a comprehensive plan, in strong collaboration with leading external global experts to educate the retina community about the positive benefit / risk profile of Beovu.   [See p. 12 of the 70-page PDF.]

We presume this Novartis plan to resurrect Beovu and get it back on its intended path of being a so-called "blockbuster" drug for Novartis in terms of sales involves its external safety review committee (SRC). In the past, Novartis has implied that this panel of experts was set up to provide an independent review of the Beovu side effects case reports. We reported on the most recent Novartis SRC findings made available to the public in this November 17, 2020 article, "Novartis Update on Patients Suffering from Retinal Vasculitis and/or Retinal Vascular Occlusion After Beovu Injections".

But one wonders what effect new Beovu lawsuits filed on behalf of individual patients who suffered severe loss of vision after receiving Beovu injections will have on eye doctors and AMD patients, alike. The first three of those Beovu lawsuits against Novartis (of which we are aware, at least) were filed during the past couple of weeks, with more to follow.

Given the serious nature and number of Beovu side effects reported to date, together with the Beovu lawsuits filed against Novartis for patients with vision loss, it seems fair to say that things look a bit grim for Beovu and Novartis at the present time.

Our law firm is investigating possible Beovu lawsuits for patients who have suffered vision loss or blindness due to Beovu side effects. If we can be of assistance to you or someone else regarding a Beovu drug injury case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

 

 

Elmiron Maculopathy Secondary to Pentosan Polysulfate (PPS) Toxicity: Medical Journal Article

New Elmiron Study Suggests Established Maculopathy Patients Should be Asked About Possible Elmiron Use

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity was first reported in this 2018 Ophthalmology medical journal article, "Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium".  Now a new Elmiron medical study about cases of macular toxicity related to PPS exposure suggests that established maculopathy patients should be questioned regarding any Elmiron use in the past.

This new study was a retrospective case series of four patients with pigmentary maculopathy, and its findings are presented in this article, "New Insights Into Pentosan Polysulfate Maculopathy", posted on January 21, 2021, by the medical journal Ophthalmic Surgery, Lasers and Imaging Retina, or OSLI Retina.

From that January 2021 medical journal article about Elmiron maculopathy we get this background information set forth in its Introduction section:

Macular toxicity secondary to pentosan polysulfate sodium (PPS) (Elmiron; Janssen Pharmaceuticals, Beerse, Belgium) was first reported in 2018. PPS is the only U.S. Food and Drug Administration (FDA)-approved oral treatment for interstitial cystitis (IC), a painful urological condition affecting approximately 45 in 100,000 women and eight in 100,000 men globally. Pearce et al. initially described six patients with PPS exposure (approximately 400 mg/day, average of 15 years) presenting with pigmentary maculopathies characterized by paracentral hyperpigmentation and nodular excrescences on optical coherence tomography (OCT) at the level of the retinal pigment epithelium (RPE) with negative genetic testing.

Subsequent articles investigated the strength of the association, described the phenotypic range of presentation, and generated screening recommendations. Diagnostic criteria described include: 1) bilateral pathology centered on the fovea, 2) paracentral macular hyperpigmented spots, 3) dense array of hyper- and hypoautofluorescent spots and reticular fundus autofluorescence (FAF) abnormalities, and 4) foci of nodular RPE enlargement on OCT corresponding to hyperreflectance on near-infrared reflectance imaging. Humphrey visual fields (HVF) ranged from normal to dense paracentral to central scotomas correlating with the degree of atrophy and analysis of electroretinography (ERG) revealed normal to diffusely dampened amplitudes. [Footnotes omitted.]

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Next, we look at the so-called "value-added" aspect of this new Elmiron medical study about cases of macular toxicity related to PPS exposure. From the Discussion section of the January 2021 OSLI Retina article:

This study provides novel information about the phenotype of PPS maculopathy. We demonstrate progression of FAF changes over 4 to 5 years (despite PPS discontinuation in one patient), collapse of nodular RPE excrescences over time, and quantification of drastic total retinal thinning in two patients during a 4- to 5-year follow-up period. We further showed FAZ abnormalities and choriocapillaris dropout on OCTA, and functional quantification of the previously reported subjective DA symptoms.

The strength of this analysis is the length of follow-up with incidental multimodal imaging over 4 years. FAF findings demonstrate increasing intensity and area of characteristic changes, and OCT data show progressive macular thinning. The choroidal thickness during the same period remained stable, whether that implies a degree of direct retinal toxicity remains to be elucidated....

Another contribution of this new Elmiron medical study to the medical literature has to do, in large part, with how one might diagnose Elmiron maculopathy secondary to pentosan polysulfate (PPS) toxicity. From the Conclusions section of the January 2021 OSLI Retina article:

Patients with long-term [use of Elmiron, i.e., exposure to PPS] may present with various pre-existing diagnoses but most PPS toxicity cases manifest with a specific constellation of OCT, FAF, and [OCT angiography (OCTA)] findings. Established maculopathy patients should be questioned regarding exposure to PPS, especially with negative genetic testing or atypical presentations. For patients with [cystoid macular edema (CME)], [carbonic anhydrase inhibitors (CAIs)] can be effective and may need to be continued long after the [Elmiron (PPS)] has been withdrawn. Patients can have progressive RPE changes even after [Elmiron] medication discontinuation, and vascular changes may imply mechanisms of toxicity involving both the choriocapillaris and RPE. The finding of significant choriocapillaris dropout may inform understanding of the pathophysiology.

Our law firm is investigating possible Elmiron lawsuits for patients who have suffered vision loss due to Elmiron maculopathy. If we can be of assistance to you or someone else regarding an Elmiron vision loss case, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Gilenya Liver Injury Risk Warnings Are Increased, Again, This Time in Canada

Similar Gilenya Drug Label Changes Were Made in Europe and UK During Past Few Months

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On January 18, 2021 Health Canada posted a Gilenya drug safety alert about patients developing Gilenya-associated liver injury, including acute liver failure requiring liver transplant. In the final two months of 2020 we saw similar Gilenya liver risk warnings announced by drug regulators in Europe and the United Kingdom (UK).

This Health Canada Dear Healthcare Professional Letter, "GILENYA (fingolimod) - Risk of Liver Injury", presented this Gilenya drug safety issue as follows:

Post-market cases of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have been reported in multiple sclerosis (MS) patients treated with GILENYA. Some of these cases have resulted in acute liver failure requiring a liver transplant.

Health Canada provided some background, as well as adding new information, in that January 2021 Gilenya drug safety alert:

The most recent periodic review of international safety data identified cases of liver failure, some requiring liver transplant, in patients treated with GILENYA. Other cases of clinically significant liver injury were also reported in patients treated with GILENYA. Signs of liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, have appeared shortly following the initiation of treatment as well as after prolonged use.

During clinical trials, an increase in hepatic enzymes was identified as a very common adverse drug reaction associated with GILENYA. Given the seriousness and severity of recently reported post-market cases, the Canadian Product Monograph (CPM) for GILENYA has been updated to further inform on the risk of liver injury and to include revised guidance for monitoring liver function and criteria for treatment interruption and/or discontinuation.

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We have written about the Gilenya drug label changes with increased liver risk warnings added in Europe and the UK in these previous articles:

• Gilenya Safety Alert November 2020: Cases of Acute Liver Failure Requiring Liver Transplant -- European Medicines Agency (EMA) and Novartis Issue Dear Doctor Letter About Gilenya Label Change
• Gilenya Associated with Cases of Liver Injury, Including Acute Hepatic Failure Requiring Liver Transplant -- January 2021 Drug Safety Update for Gilenya Issued by Medicines and Healthcare products Regulatory Agency

In the US, the Gilenya drug label was revised back in November to add warnings about Gilenya-associated liver injury, including acute liver failure requiring a liver transplant. See 5 WARNINGS AND PRECAUTIONS, 5.5 Liver Injury.

We will watch to see whether the FDA mandates any further Gilenya drug label changes with increased liver risk warnings here in the US going forward.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Elmiron Lawsuits Federal Court MDL is Created in December 2020, Assigned to Judge Martinotti

Legal Cases Involve Elmiron Causing Eye Damage and Retinal Injury Such as Atypical or Pigmentary Maculopathy

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On December 15, 2020, the Judicial Panel on Multidistrict Litigation (JPMDL) granted a plaintiffs’ motion to centralize all currently filed federal court lawsuits involving the bladder drug Elmiron and assigned that multidistrict litigation (MDL) to the U.S. District Court for the District of New Jersey. This Elmiron MDL was assigned to U.S. District Judge Brian Martinotti, who oversee these Elmiron lawsuits which allege that Elmiron -- a pill used to treat chronic bladder infection called interstitial cystitis -- can cause Elmiron-related eye problems that can lead to vision loss or blindness.

In this September 2020 article, "Elmiron-Related Eye Problems Are Causing Patients to File Elmiron Lawsuits Against Pharmaceutical Companies", we explained the factual basis for the Elmiron lawsuits which will be included in this new Elmiron MDL:

Elmiron (pentosan polysulfate sodium / "PPS") was approved by the FDA in 1996 for the treatment of interstitial cystitis ("IC"), also known as “bladder pain syndrome” or “painful bladder syndrome”. In recent years, however, there have been reports of patients who used Elmiron developing vision loss due to Elmiron-related maculopathy. But there were not any warnings about these Elmiron eye problems in the Elmiron Prescribing Information document, or drug label, until June 2020, when the FDA mandated an Elmiron label change. This situation has resulted in Elmiron lawsuits filed by patients who have vision loss due to Elmiron.

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From the Transfer Order issued for In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MDL Docket No. 2973, we get the following legal information:

Plaintiffs in the District of New Jersey Dobbins action move under 28 U.S.C. § 1407 to centralize this litigation involving retinal injuries associated with the use of Elmiron (pentosan polysulfate sodium)....

No responding party opposes centralization....

After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]

We are currently investigating possible Elmiron lawsuits for patients diagnosed with Elmiron-related eye problems such as:

• wither pigmentation maculopathy
• pigmentation macular degeneration
• pigmentation maculitis
• retinal maculopathy
• dry macular degeneration

We point out that a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor in order to be in a position to file an Elmiron lawsuit.

If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

How Beovu Went from Potential Blockbuster AMD Drug for Novartis to Possible Beovu Drug Recall in 2021

Key Events for Beovu 2019 - 2020: FDA Approval, Safety Alerts and Warnings, Drug Label Changes, Novartis Investigation

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Leading up to the October 2019 launch of Beovu here in the US, Novartis was hoping its new age-related macular degeneration (AMD) drug would compete with Eylea and Lucentis, which were more established AMD drugs. But then came the unwanted Beovu adverse drug reactions and Beovu-related eye problems, with numerous reports of Beovu causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation.

In this article, we walk you through the key events for Beovu in 2019 and 2020 that seem to have moved Beovu away from being a blockbuster AMD drug for Novartis and toward the possibility of there being a Beovu drug recall in 2021.

To start, Beovu was approved by the FDA on October 7, 2019, for the treatment of wet age-related macular degeneration (AMD).

From the outset, this launch of Beovu in the US was a bit rocky for Novartis, as seen by this excerpt from an October 8, 2019, Fierce Pharma piece, "Novartis takes on Regeneron, Roche blockbusters with Beovu approval":

The drug won approval for 8- and 12-week dosing intervals after a three-month loading phase of monthly injections. But SVB Leerink analysts pointed out that the label carries “higher safety liabilities” than Eylea. In the phase 3 trials, patients on Beovu were four times as likely to have intraocular inflammation than those on Eylea, at 4% and 1%, respectively.

Then on February 23, 2020, the American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis across 46,000 injections since Beovu’s launch, as reported by this news report, "Novartis' hot new eye drug Beovu tied to potential vision loss: experts".

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Battling back, a week later Novartis stated the current prescribing information document for Beovu sufficiently addresses its risks of intraocular inflammation and retinal artery occlusion. You can read more about that position in this March 2, 2020, article, "Novartis stands behind Beovu's safety, benefits after vision-loss warning".

About a month later, however, we saw this April 6, 2020,  BioPharmaDive item, "Eye drug side effects are real, Novartis confirms in new warning", reporting Novartis said it would work with the FDA, the European Medicines Agency (EMA), and other drug safety regulators around the world to issue a revised Beovu drug label with new warnings about Beovu-related eye problems.

Next, as announced in this June 9, 2020 Supplemental Approval letter, the FDA approved a label update for Beovu whereby Novartis will add warnings and safety information about retinal vasculitis and retinal vascular occlusion, which can lead to vision loss and blindness.

This was followed a few months later by the September 14, 2020, Novartis Media Release item, "European Medicines Agency (EMA) approves safety label update for Novartis Beovu®".

And lastly, there is this November 14, 2020 Reuters news report, "Novartis identifies possible risk factors for Beovu patients".  Summarily it let us know that, according to a safety review issued by Novartis, the main risk of experiencing Beovu adverse drug reactions such as retinal vasculitis and/or retinal vascular occlusion within the six months after the first administration of Beovu was prior intraocular inflammation and/or vascular occlusion in the year prior to the first injection of Beovu.

We will watch for further developments concerning these various Beovu adverse drug reactions and Beovu-related eye problems, as well as indications of a possible Beovu drug recall in 2021.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)