Pharmaceutical Drug Litigation Updates

FDA Let Risky Drugs Hit Market, Article Says

Quoted from http://professional.wsj.com/article/SB10000872396390443571904577631883702006726.html

Article Says Agency Let Risky Drugs Hit Market

By THOMAS M. BURTON

September 4, 2012

An FDA effort to speed approval of new medicines allowed drugs for stroke prevention, cancer and multiple sclerosis onto the market without proper safety analysis, according to two drug-safety experts.

In an article to be published Wednesday in the Journal of the American Medical Association, Thomas J. Moore and Curt D. Furberg wrote that the Food and Drug Administration's push to get medicines to market may have compromised prescription-drug safety. They cite an MS drug with apparent adverse effects on the heart and many other risks, and an anticoagulant linked to bleeding that is proving difficult to treat.

"These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered," Mr. Moore and Dr. Furberg wrote.

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Patients must be monitored after taking first dose of MS drug: Health Canada

Quoted from http://www.montrealgazette.com/health/all/Patients+must+monitored+after+taking+first+dose+drug+Health/7136291/story.html

Patients must be monitored after taking first dose of MS drug: Health Canada

By The Canadian Press August 24, 2012

OTTAWA - The manufacturer of a drug used to treat multiple sclerosis is issuing new safety recommendations aimed at reducing the risk of serious heart-related side-effects when patients first start taking the medication.

Novartis Pharmaceuticals Canada Inc. said its drug Gilenya (fingolimod) causes the heart rate to slow down in the first hours after ingestion, but it returns to normal after about a month of treatment.

Gilenya can also cause an irregular heartbeat, especially after the first dose, Novartis said in a Health Canada advisory Thursday.

Isolated cases of adverse effects on the heart, including temporary but serious irregularity in heart beat and one case of unexplained death, have also been observed within 24 hours of the first pill, possibly associated with Gilenya, the advisory said.

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EU to rule on safety of Novartis's Gilenya MS pill

Quoted from http://www.marketwatch.com/story/eu-to-rule-on-safety-of-novartiss-gilenya-ms-pill-2012-04-18

EU to rule on safety of Novartis's Gilenya MS pill

By Marta Falconi

April 19, 2012

ZURICH (MarketWatch) -- Europe's drug regulator will likely allow Novartis AG's Gilenya to stay on the market without asking for much stricter safety warnings as it concludes a review of the multiple sclerosis pill initiated after reports of heart problems and the death of a patient who took the drug.

The regulator's decision could come as early as Thursday, said the London-based European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago.

The EMA launched the in-depth study in January to assess Gilenya's benefits and risks, and recommended doctors closely monitor the hearts of patients after they have been given the first dose of the drug.

The review was prompted by reports of heart problems in patients taking Gilenya, as well as the November death of a 59-year-old patient in the U.S. less than 24 hours after taking the first dose of the drug. The EMA had aimed to give an update on Gilenya's safety in March, but delayed its decision by about a month as it finalizes its review.

The U.S. Food and Drug Administration also announced a safety review of Gilenya in December, saying there wasn't a clear cause of the patient's death. There is no time frame for the FDA's review.

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Novartis MS Pill Gilenya Patient Gets Rare Brain Disease

Quoted from http://online.wsj.com/article/BT-CO-20120413-704136.html

Novartis MS Pill Gilenya Patient Gets Rare Brain Disease

By Marta Falconi

Of DOW JONES NEWSWIRES

ZURICH (Dow Jones)--Novartis AG (NVS) Friday said a patient treated with its multiple-sclerosis pill Gilenya has been diagnosed with a rare and often fatal brain disease.

The Swiss drug maker said the patient, whose identity has not been disclosed, had been previously treated with another MS drug, Tysabri, co-marketed by Biogen Idec Inc. (BIIB) and Elan Corp. PLC (ELN), which has been already associated with progressive multifocal leukoencephalopathy, or PML.

"The current assessment is that Tysabri is the drug most likely associated with this case of PML," Novartis said in a statement. "However, a contribution of Gilenya to the evolution of this case can't be excluded."

The development comes at a critical time for Novartis' Gilenya, whose safety profile has recently come into question after the death of one person in the U.S. last autumn within 24 hours of starting treatment. Heart problems in some patients were also reported.

The European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago, is expected to issue a decision on the safety of the medicine following an in-depth review on April 20.

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Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths

Quoted from http://www.businessweek.com/news/2012-01-20/novartis-s-gilenya-pill-reviewed-by-eu-u-s-after-11-deaths.html

Novartis’s Gilenya Pill Reviewed by EU, U.S. After 11 Deaths

January 20, 2012, 12:27 PM EST

By Simeon Bennett

 

Jan. 20 (Bloomberg) -- European and U.S. regulators are reviewing Novartis AG’s Gilenya pill for multiple sclerosis after reports of 11 deaths among patients who took the drug. The shares fell the most in more than five months.

The reports raise concern that Gilenya, the first oral treatment for the debilitating neurological disease, may harm the heart, the European Medicines Agency said in a statement today. The U.S. Food and Drug Administration said it’s also reviewing data on the medicine.

Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya. Ten other deaths have been reported among patients who began taking the drug, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.

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Gilenya trial could ease safety worries

Quoted from http://www.reuters.com/article/2011/12/15/us-novartis-idUSTRE7BE0GM20111215

Gilenya trial could ease safety worries

ZURICH | Thu Dec 15, 2011 2:25am EST

ZURICH (Reuters) - A third late-stage trial of Novartis' multiple sclerosis drug Gilenya did not throw up any new safety issues with the pill, going some way to alleviating concerns about possible risks linked to the potential blockbuster.

The study results come just days after Novartis said it was looking into whether the pill had caused the death of a 59-year-old patient who had just started therapy.

But Novartis said there had been no deaths in patients treated with Gilenya on the trial and that safety and tolerability were broadly consistent with the safety profile of the medicine in previous Phase III trials.

This study, known as Study 2309, was mainly carried out to give specific safety data for the Gilenya New Drug Application that was submitted to the U.S. Food and Drug Administration at the end of 2009. Gilenya has since won approval there.

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Novartis: Patient Died After Starting Gilenya

Quoted from http://www.bloomberg.com/news/2011-12-12/novartis-patient-died-after-starting-gilenya.html

Novartis: Patient Died After Starting Gilenya

By Naomi Kresge - Dec 12, 2011 12:32 PM ET

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

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