Washington Editor

As the dog days of summer come to a close, it has yet to be seen whether 2008 will be a dog of a year for drug approvals, as was 2007, with only 16 new molecular entities (NME) and two new biologics approved last year - the lowest number of novel medications approved in the past half century.

While big pharma's approvals so far this year have been mainly for new formulations of drugs, most of the NME and new biologic approvals have been for products made by biotechnology companies.

The FDA has approved a little more than 50 new drug applications (NDAs) and biologics license applications (BLAs) since January, with most receiving a standard review of at least 10 months or more.

Only about 10 NDAs or BLAs have received a six-month priority review since January, with three of those medications tentatively approved under the President's Plan for AIDS Relief, or PEPFAR.

In 2007, there were 78 NDAs and two BLAs approved, in addition to 10 PEPFAR application approvals.

Zurich, Switzerland-based Nycomed AS, whose U.S. division is located in Melville, N.Y., achieved the first FDA drug approval in 2008 with its asthma medication Avesco (ciclesonide) on Jan. 10.

However, Tibotec Inc., of Yardley, Pa., received the first approval this year of an NME on Jan. 18 for its HIV drug Intelence (etravirine).

Other biotech NMEs that have gained approval this year include Cephalon Inc.'s Treanda (bendamustine, March 20), CV Therapeutics Inc.'s Lexiscan (regadenoson, April 10), Progenics Pharmaceuticals Inc.'s Relistor (methylnaltrexone bromide, April 24), Adolor Corp.'s Entereg (alvimopan, May 20), Sirion Therapeutic Inc.'s Durezol (difluprednate, June 23), the Medicine Co.'s Cleviprex (clevidipine butyrate, Aug. 1) and Prestwick Pharmaceutical Inc. Xenazine (tetrabenazine, Aug. 15).

Pharma giants Wyeth and Bayer were the only other drugmakers that have achieved approvals of their NMEs thus far in 2008, with Pristiq (desvenlafaxine, Feb. 29) and Eovist (gadoxetate, July 3), respectively.

Regeneron Pharmaceuticals Inc.'s Arcalyst (rilonacept, Feb. 27), UCB SA's Cimzia (certolizumab pegol, April 22) and Amgen Inc.'s Nplate (romiplostim, Aug. 22) are the only new biologics that have gained FDA approval so far this year.

The FDA has been criticized over the past few years for lagging in getting new treatments to the market, while at the same time being accused by Congress and patient advocates of being too cozy with drug firms and not doing enough to protect the public. The agency in April announced it was hiring 1,300 new scientists and others with medical backgrounds to bolster its work force.

Regulators said the new personnel will aid the FDA in shortening its review times and catching up on its backlog of pending applications.

"It takes a large pool of talented people for the FDA to protect and promote the public health," said John Dyer, FDA's deputy commissioner for operations and chief operating officer. "Each month there is a delay in bringing critical staff on board impairs the agency's ability to fulfill this mission," he said in a statement.

The agency set a goal of filling 700 open positions and 600 newly created jobs by October.

However, it is unclear whether the new personnel will make a difference in drug approvals this year.

What also remains to be seen is whether the FDA will continue with a growing trend of postponing Prescription Drug User Fee Act (PDUFA) action dates, which could push several pending approvals into 2009.

For instance, Horsham, Pa.-based Centocor Inc.'s PDUFA date for its psoriasis drug ustekinumab recently was extended from September to December.

About 15 drugs whose applications are under review currently have PDUFA dates set to be acted on before year-end, including CSL Behring's Berinert P (C1-esterase inhibitor), Roche AG's Actemra (tocilizumab), Genzyme Corp.'s Mozobil (plerixafor) and Introgen Therapeutic Inc.'s Advexin.