FDA Advisory Panels Recommends Fewer Drugs This Year

Source: FDA-OCIImage via Wikipedia It has been a rough year for Drug Candidates this year. Time after time FDA panels are rejecting more qualified drug approvals. So what really is going on here. Are drug up for FDA approval less safe, less effective, or are the panels more cautious on approvals. These panels have had a devastating effect on the company's stock after these No recommendations. Let's take a closer look into what's really going on.

FDA Advisory Panels: A Coin Flip

Adam Feuerstein TheStreet.com Senior Columnist

BOSTON (TheStreet) -- Investors who think they can predict the outcome of U.S. Food and Drug Administration advisory panels this year might be better off just flipping a coin.

FDA advisory committees have become much tougher in 2010 with only a bit more than half of drugs taken in front of panels receiving positive recommendations, according to an analysis conducted by Concept Capital, the healthcare policy research arm of Sanders Morris Harris.

As of August 26, FDA advisory committees have recommended approval 12 out of 23 times, or a rate of just 52%, according to Concept Capital.

"The percentage of 'yes' recommendations is down significantly compared to 2009 and 2008, when 75% and 80% of drugs received positive recommendations," said Ramsey Baghdadi, an analyst with Concept Capital.

Notable "no" votes from advisory panels this year include Cell Therapeutics' (CTIC) lymphoma drug pixantrone, Vivus' (VVUS) obesity drug Qnexa, Acura Pharmaceuticals' (ACUR) pain drug Acurox and Jazz Pharmaceuticals' (JAZZ) fibromylagia drug JZP-6.

The 52% rate of positive votes is similar to the 50% rate in 2007, considered to be one of the worst regulatory periods for the pharmaceutical and biotech sectors in years, said Concept Capital, in its analysis.

So far this year, the Oncologic Drugs Advisory Committee has voted against approval for all three cancer drugs it has reviewed this year. Conversely, the Peripheral and Central Nervous System Drugs Advisory Committee has been the most amenable, recommending approval all three times for drugs from Questcor Pharmaceuticals (QCOR), Novartis (NVS) and Valeant Pharmaceuticals (VRX).

Upcoming FDA advisory panel meetings will review drugs from Arena Pharmaceuticals (ARNA), Alkermes (ALKS), and Forest Labs (FRX).

Here's a list of 21 drugs facing FDA drug approval decisions and advisory panels through the end of the year.

Concept Capital's Baghdadi says FDA advisory panels have become more unpredictable for two main reasons: First, the FDA is bringing more drugs in front of advisory panels due to changes in FDA law that require most new drugs to be reviewed by outside experts. Second, stricter conflict of interest rules implemented by FDA have made it more difficult for the agency to recruit experienced panel members.

Despite the tougher stance at FDA advisory panels, Concept Capital believes the overall environment for drug approvals at FDA is improved compared to prior years.

Concept Capital limited its analysis to new molecular entities and major new indications for currently approved drugs that were reviewed by advisory panels attached to the FDA's Center for Drug Evaluation and Research.

A broader look at FDA advisory panel, including biologic drugs and those reviewed by other FDA divisions offers a bit more optimistic picture -- 15 "yes" votes from 27 panels, or a 56% rate.
Enhanced by Zemanta

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.