Will These Drugs Get Past the FDA?

Another month is here -- this Fool's favorite one -- and we've got plenty of drugs due for decisions by the Food and Drug Administration. Before we begin with the individual drugs, a couple of brief reminders about decision dates:

  • The Prescription Drug User Fee Act (PDUFA) sets a goal for the FDA to review drug marketing applications within 10 months for standard reviews and six months for priority reviews.
  • The PDUFA dates come from those goals, but they can -- and most recently will -- be missed.
  • Don't try and jump in and out around the PDUFA date. Find a drug owned by a drugmaker you like and buy when the price is right and hold until the FDA makes a decision -- whenever that may be.

Double dose of diabetes drugs
A pair of diabetes drugs that had FDA advisory panel meetings last week could hear about their approvals this month, but investors shouldn't hold their breath -- Eli Lilly (NYSE: LLY  ) is still waiting to hear about prasugrel -- two months after its advisory panel meeting.

AstraZeneca and Bristol-Myers Squibb (NYSE: BMY  ) have a PDUFA date of April 30 for Onglyza. The FDA put the drugmakers in a predicament by increasing the requirements for approval after Bristol-Myers submitted its marketing application. The parties seem to have reached a compromise that works for the advisory panel -- it voted 10-2 that the drugmakers had proven that the drug carried a low risk of heart problems.

While the regulatory risk for Onglyza is minimal -- I think it's likely that the FDA will give the drug an OK eventually -- it's not clear that the drug will be a big seller. Onglyza is in the same class as Merck's (NYSE: MRK  ) Januvia and doesn't appear to be remarkably better. With Januvia having been on the market for a while, it's going to be hard for Onglyza to unseat it, especially with doctors worried about potential heart issues in diabetes drugs (like those seen in GlaxoSmithKline's (NYSE: GSK  ) Avandia).

The PDUFA date for Novo Nordisk's (NYSE: NVO  ) liraglutide already passed, but the FDA was waiting for the panel of experts to help the agency make a decision about the drug. Unfortunately the panel deadlocked over whether thyroid cancer seen in rats and mice given the drug is troubling enough to keep the drug off the market. Without a clear mandate from the experts, the agency will probably take quite awhile to make a decision and a complete response letter asking for longer human trials may be the likely outcome here.

Me, too!
Johnson & Johnson's (NYSE: JNJ  ) golimumab may be targeting the same TNF molecule as the other anti-inflammatories, but it looks like a winner for the treatment of rheumatoid arthritis and psoriatic arthritis, especially in patients that have failed other treatments. The drug has a good shot at getting past the FDA this month.

Golimumab's future in Europe is less certain -- not in terms of whether it'll get approved, but who will market it. Schering-Plough (NYSE: SGP  ) has a deal with Johnson & Johnson to market Remicade and follow-ons including golimumab, but Schering's acquisition by Merck throws a wrench in the deal. Merck structured the deal so that technically Schering-Plough was buying Merck to avoid the change in ownership clause, but whether Johnson & Johnson will let that fly remains to be seen. The health-care giant certainly doesn't need Schering/Merck to market the drug -- the agreement is left over from a company that Johnson & Johnson bought and it seems likely that Johnson & Johnson will work out some deal for the overseas rights.

Worth a closer look
Here's a few more drugmakers that could hear about their drugs this month:




Discovery Labs


After three approvable letters, will the drug to treat respiratory death syndrome finally get past the agency?



Even if it gets past the FDA, launching a competitor to Allergan's Botox might be tough.

Savient Pharmaceuticals


The drugmaker got a priority review because of the lack of treatments for gout, but that doesn't guarantee success.

Binary events are what make investing in drug companies so lucrative, and risky. Just make sure you do plenty of homework and keep the small ones like Discovery Labs and Savient at a fraction of your portfolio.

Stock news, financial commentary, and your daily dose of Foolishness: Get plugged in to The Motley Fool on Twitter!

Novo Nordisk is a Motley Fool Global Gains selection. GlaxoSmithKline and Johnson & Johnson are Income Investor recommendations. Try any of our Foolish newsletters today, free for 30 days.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.

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