FDA's new molecular entity drug approval tally for 2004 represents a five-year high for the agency.

Pfizer's Lyrica (pregabalin) cleared FDA Dec. 30, becoming the 31st and final new molecular entity NDA approved by the agency during the year. The total is 10 higher than the 21 NMEs cleared by the agency in 2003, and is the highest single year count since 1999, when FDA approved 35 NMEs (¹ Also see "FDA Clears 21 NMEs In 2003; Average Approval Time Is 16.6 Months" - Pink Sheet, 5 January, 2004., p. 5).

The total is nearly double the number of NMEs approved in 2002, when FDA cleared a 20-year low of 17 NMEs.

With FDA facing scrutiny of its handling of post-marketing safety surveillance, it may be difficult for the agency to match the 2004 total in 2005. Nevertheless, the relatively high number of NMEs entering the market may be an important indication of the long term health of the industry.

In handicapping the prospects for NDA approvals in 2005, it may be significant that 14 of the 31 NMEs were cleared after the Sept. 30 withdrawal of Merck's Vioxx .

In fact, eight were approved during the last two weeks of the year when the adverse publicity about FDA's regulatory process was at a peak.

FDA has also reported that it received more NME submissions during fiscal 2004 than it did in the prior year (² 'The Pink Sheet' Nov. 1, 2004, In Brief).

[Editor's Note: A full analysis of FDA's 2004 drug approvals - and a look ahead to potential 2005 approvals - will appear in "The Pink Sheet" Year-In-Review. It will be mailed to subscribers in February.]

Against the backdrop of the drug safety concerns, the Dec. 30 approval of Lyrica was an appropriate way for the agency to end the year.

The long-awaited Neurontin successor was the third NME approved in 2004 that will be marketed by Pfizer (along with Boehringer-Ingelheim's Spiriva and Eyetech's Macugen ).

However, the limited indications for Lyrica - and the unexpected decision to treat the drug as a controlled substance - turned the approval into another in a series of bad news events for Pfizer (see ³ Also see "Pfizer Lyrica Launch Awaits Controlled Substance Scheduling" - Pink Sheet, 10 January, 2005. ).

Lilly and Aventis each received two NME approvals during the year: the oncologic Alimta and the antidepressant Cymbalta for Lilly, and the fast-acting insulin Apidra and antibiotic Ketek for Aventis.

One unusual feature of the NME class of 2004, however, is the relatively small percentage of approvals that went to top 10 pharma companies.

Novartis received approval of the overactive bladder treatment Enablex (darifenacin), and Amgen received approval of hyperparathyroidism treatment Sensipar (cinacalcet).

The other top pharma companies were either shut out (Merck, J&J) or in-licensors (like GlaxoSmithKline with Yamanouchi's Vesicare ).

Abbott's Ross Labs division received one NME approval for Omacor , but the company is no longer involved with the product, which was licensed from the Norwegian firm Pronovo Biocare and will be marketed by Reliant.

FDA's official tally of NME approvals in 2004 will also include four therapeutic biologics reviewed by the Center for Drug Evaluation & Research.

The agency transferred most BLAs to CDER under a reorganization announced in 2003 (⁴ [A#00650520005], p. 27).

During the year, CDER cleared Genentech's Avastin , Bristol/ImClone's Erbitux , Pallatin's NeutroSpec , and Biogen Idec/Elan's Tysabri .

Although CDER has concluded that its technical definition of a "new molecular entity" does not apply to biologics, the agency intends to include BLAs for never-before-marketed products in its year-end analyses going forward.

That will raise the official tally for 2004 to 35 approvals; comparisons to prior years would have to include therapeutic biologics approved by the Center for Biologics Evaluation & Research.

FDA New Molecular Entity Approvals Rebound In 2004; Lyrica Is Fitting Finale

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