PHARMACY

New drug application review for Exenatide extended

BY Allison Cerra

INDIANAPOLIS A diabetes drug developed by Amylin, Eli Lilly and Alkermes will be reviewed by the Food and Drug Administration March 12.

The revised action date of Exenatide once weekly is the result of the FDA’s decision to allow five additional days for its review of pending regulatory applications following the agency’s recent five-day weather-related closure.

Exenatide once weekly is an investigational, extended-release medication for Type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.

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District court rules against FTC in patent settlement suit

BY Alaric DeArment

ARLINGTON, Va. A federal court has ruled in favor of Solvay Pharmaceuticals in an antitrust lawsuit brought by the Federal Trade Commission alleging that Solvay conspired with generic drug makers to postpone generic competition for a testosterone-replacement drug.

The FTC had accused Watson Pharmaceuticals and Par Pharmaceutical Cos. of agreeing with Solvay to delay entry of their versions of the drug AndroGel in a settlement that would allow the launch of the generic versions in 2015, five years prior to the expiration of the patents covering the drug, in August 2020. U.S. District Court judge Thomas Thrash, in Atlanta, dismissed the FTC’s challenge, ruling that it had no case against the settlement.

“This decision, along with several other prior court decisions in similar suits brought by the FTC, reaffirms the pro-competitive and pro-consumer nature of patent settlements,” Generic Pharmaceutical Association president Kathleen Jaeger said in a statement. “The decision further demonstrates that the existing authority of the FTC to review patient settlements and contest those that they deem to be anti-competitive adequately protects consumers.”

The GPhA has lately fought efforts by the FTC to ban patent settlements between brand and generic drug companies. Such settlements are common in patent infringement lawsuits brought by brand drug companies, filed when a generic drug company seeks to market its version of a drug before the brand drug’s patent expires. According to a report by the Royal Bank of Canada, most of the settlements allow generic entry into the market before patent expiration, though some have labeled them “pay-for-delay” settlements. GPhA president Kathleen Jaeger has told Drug Store News that the label is inaccurate, and that delaying generic entry after the patent had expired would be illegal.

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FDA gives Fabry disease treatment ‘fast track’ designation

BY Alaric DeArment

CAMBRIDGE, Mass. The Food and Drug Administration has given “fast track” designation to an approval application for a drug made by Shire, the British drug maker announced Wednesday.

The FDA granted the designation to Replagal (agalsidase alfa), an enzyme-replacement therapy for Fabry disease. Fabry disease is a lysosomal storage disorder that diminishes the ability to break down the fatty substance Gb3 and can reduce patients’ life spans by 15 to 20 years.

Shire filed a biologics license application for Replagal in December. The FDA requested additional human pharmacokinetic data to confirm its compatibility with biotech drugs manufactured in roller bottles, as the drug is manufactured using a device called a bioreactor. Drugs made in bioreactors are already approved in the European Union and other countries.

On account of the request, Shire withdrew its regulatory filing, but at the suggestion of the FDA, requested and received the fast track designation, which the FDA gives to drugs to facilitate development and expedite review of drugs that treat serious diseases and fill unmet medical needs. Shire said it plans to resubmit the application and will submit the requested data in the middle of the year.

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