NME

2008 NME approvals will surpass 2007

Maureen Martino — Fri, 21 Nov 2008 09:55:49 -0500

Last year was one of the bleakest on record in terms of new drug approvals. Only 18 new molecular entities were approved by the FDA--the lowest number since 1983. The first half of 2008 was nothing to brag about either, as the industry seemed to be destined to repeat its lackluster performance the year before.

But In Vivo reports that this year promises to be slightly better. That's because the FDA has already approved 18 NMEs, and there are still six weeks left in the year. Ten more drug applications could be approved before the end of the year. If that happens, 2008 would be the best drug-approval year since 2004, when the agency approved 38 NMEs.

One good year won't solve the industry's problems. What's really needed is consecutive years of sustained new drug output. However, "the thought that FDA will end up approving more drugs this year than last offers a much-needed sign of hope for the biopharma industry. Maybe--just maybe--the new era in drug regulation ushered in by the FDA Amendments Act of 2007 won't be so bad after all," observes In Vivo's Michael McCaughan.

- see the blog post

GSK's Garnier: FDA raised the bar for new drugs

Fri, 16 May 2008 06:59:55 -0400

In an interview with the Financial Times, outgoing GSK CEO Jean-Pierre Garnier shares his thought on the new, tougher FDA approval environment. While many drug developers hope the FDA's reticence to approve new drugs in the wake of recent safety scandals will fade over time, Garnier think the regulatory environment is irrevocably changed.

"The hurdle rate has gone up. It is not going to come down. This is not a pendulum. Society wants to avoid risk. We have to tease out rare side-effects earlier," Garnier observed. Blockbusters as we know them are a dying breed. Instead, he predicted that there will be more "progressive blockbusters," drugs approved for one indication that gain other approvals over time. This approach minimizes the risk that a marketed drug could cause serious side effects that were not observed during clinical trials.

- for more on Garnier's thoughts, see this article

FDA picking up the pace on '08 approvals

Thu, 15 May 2008 06:59:58 -0400

Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 new drug approvals through April, the fastest rate of acceptance since 1998 and 2000. And that's way up from the anemic 16 approvals posted for the same period last year. But ten of the 29 approvals are for therapies that build on existing drugs and there were only three NME approvals for the period.

"We view NME approval trends as a more critical metric than overall new drug approval trends because NMEs represent novel compounds carving out entirely new pharmaceutical niches. These are the compounds that break new clinical ground and require the most effort in educating physicians, patients, and payers," writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey.

- read the report in Pharmalot

FDA rejections signal tougher developers standards

Wed, 30 Apr 2008 06:59:58 -0400

Faced with back-to-back rejections of two would-be blockbuster drugs for cholesterol, analysts have been reading the tea leaves for what this could portend for developers. What they've come up with boils down to a tougher set of standards for cholesterol drugs and a much more skeptical view of me-too drugs. Regulators are increasingly interested in seeing data regarding superior benefits over existing meds. And that will take more time and money to produce.

"The party for all these 'me-too' drugs has been over for at least two years," WBB Securities analyst Steve Brozak told the AP. "It's just that these pharmaceutical companies are only now beginning to realize it."

It seems clear now that the FDA--in the wake of the Vytorin fiasco--will demand data on new cholesterol drugs demonstrating that they can improve outcomes rather than simply influence cholesterol levels.

- check out the AP report

Developers: Politics behind slow approval process

Wed, 26 Mar 2008 07:59:57 -0400

Woodcock's defense, though, may seem particularly hard to accept at a slate of big pharma companies which have been able to win European approvals only to run straight into a roadblock at the U.S. agency. Galvus, Acomplia and Cervarix have all been OK'd by the European Medicines Agency, but are still languishing at the FDA. And Novartis says it may simply skip the U.S. market for Galvus if the feds raise the bar too high for the diabetes drug. The Wall Street Journal notes that a number of analysts believe the FDA faces a higher degree of public and political pressure during the approval process--precisely the kind of influences that Woodcock rejects as a significant factor.

"The scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill," says James Shannon, Novartis' departing head of drug development. "I think it results in them taking decisions which are conservative."

- read the story in the Wall Street Journal

Related Articles:
FDA getting tougher with refuse-to-file letters. Report
The FDA: Caught between a rock and a hard place. Report
FDA quick to reject drugs as it gets more cautious. Report
Dry spell or parched desert for NME approvals? Report
Blogster sees lessons in FDA approvable letters. report

2008 NME approvals no better than last year?

Wed, 12 Mar 2008 07:59:54 -0400

In 2007, there was much ado about the slow pace of new molecular entity (NME) approvals. Though over 200 drugs were approved in 2007, only 19 of them represented groundbreaking advances in medicine.

In 2008, according to a post on Pharmalot, the industry is set to repeat last year's lackluster performance. Thus far the FDA has approved 14 NDAs but only one NME--the same rate of approval as last year. Why so slow? Analyst Jim Kumpel of Friedman Billings Ramsey says the FDA is hard at work implementing initiatives that resulted from PDUFA reauthorization. Others, including industry execs, are likely to blame the slowdown on a skittish post-Vioxx FDA that's suffered serious criticism for approving unsafe drugs.

- here's the Pharmalot item
- see the full list of 2007 FDA approvals

Related Articles:
Dry spell or parched desert for NME approvals? Report
'07's drug approval record raises worries. Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report