FDA enters the fourth quarter with at least 28 pending applications with October user fee deadlines, including seven new molecular entities and one new biologic.

The large October grouping reflects the 2002 year-end rush in submissions and should help the agency top the 17 NMEs cleared in 2002 (¹ Also see "New Drug Approvals In 2003 Could Include Four HIV Agents" - Pink Sheet, 30 December, 2002., p. 3). FDA already has a good start on 2003 NME approvals: the current tally is 14.

FDA attributed the low number of approvals in 2002 to a slowdown in submissions, a trend that appears to have at least moderated. The seven NMEs and 28 applications with user goals in October are more than double the respective numbers of disclosed applications that were due last October.

Several of the pending NMEs, however, face obstacles to a timely approval. Only four of the seven - Yamanouchi's solifenacin, Novartis' Enablex (darifenacin) and Certican (everolimus), and GlaxoSmithKline's fosamprenavir - have not showed indications of delay. [Editors' note: This story first appeared in FDC Reports' ² Pharmaceutical Approvals Monthly . Sample copies are available; contact Dzidra Vizbulis at 800-332-1370.]

Yamanouchi's solifenacin for relief of symptoms of urinary frequency, incontinence and urgency has a user fee goal of Oct. 19. Novartis' overactive bladder treatment, darifenacin, could see action a few days earlier. Both products are selective M3 muscarinic antagonists.

GSK/Vertex' protease inhibitor fosamprenavir has an Oct. 20 action date for combination treatment of HIV. Despite the failure of its prodrug - GSK's Agenerase (amprenavir) - to show non-inferiority to a lopinavir/ritonavir regimen in treatment-experienced patients in a recent study, Vertex expects approval in both treatment-naïve and treatment-experienced patients.

Novartis' Certican for prevention of rejection episodes following heart and kidney transplantation also has an Oct. 20 user fee date. The proliferation inhibitor yielded a significantly smaller incidence of death or transplant complications compared to azathioprine in a 634-patient cardiac transplantation study published in the Aug. 28 New England Journal of Medicine.

CV Therapeutics' chronic angina agent Ranexa (ranolazine) is among the NMEs that appear unlikely to gain approval by their user fee goals. CVT is anticipating an action letter or user fee extension following the cancellation of the September review by FDA's Cardio-Renal Drugs Advisory Committee (³ Also see "Ranexa Advisory Cmte. Review Cancelled; User Fee Date May Be Extended" - Pink Sheet, 11 August, 2003., p. 33). An extension would allow for a later committee review; the next tentative meeting date is Dec. 8-9.

First-cycle approval appears questionable for Forest's Alzheimer's agent Namenda (memantine), which has a user fee date of Oct. 19. Forest had indicated that it expects to receive an "approvable" letter. However, FDA's Peripheral & Central Nervous System Drugs Advisory Committee's conclusion Sept. 25 that the drug showed a small but consistent effect in moderate to severe patients could be a boost for the application.

Lilly had been predicting clearance for its "approvable" Cymbalta (duloxetine) in the fourth quarter, but received a second "approvable" letter for the antidepressant Sept. 29. FDA deemed a separate application for use in stress urinary incontinence "approvable" Aug. 28 (⁴ Also see "Lilly Cymbalta Approval Timeline In Doubt After Delay In Second NDA" - Pink Sheet, 8 September, 2003., p. 4).

Lilly has another "approvable" NME with action due in the fourth quarter: Cialis is expected to be the third erectile dysfunction agent to reach market.

GSK's COPD therapy Ariflo (cilomilast) hit a major snag in approval with the Pulmonary-Allergy Drugs Advisory Committee's Sept. 5 review. The committee voted 7 to 3 that the agent did not show a "magnitude and consistency of efficacy that is sufficient to support approval" (⁵ Also see "Ariflo COPD Long-Term Efficacy Studies Should Use Active Controls – Cmte." - Pink Sheet, 15 September, 2003., p. 22).

Cephalon expects to receive an "approvable" letter for its narcolepsy drug Provigil (modafinil) by the Oct. 20 user fee date. FDA's Peripheral & Central Nervous System Drugs Advisory Committee voted for approval for sleep disruption and circadian misalignment Sept. 25, but split over a broader indication for excessive sleepiness associated with disorders of sleep and wakefulness (⁶ Also see "Provigil Likely To Add Two New Claims; Broad Sleepiness Indication May Wait" - Pink Sheet, 29 September, 2003., p. 25).

Genentech/Xoma's psoriasis therapy Raptiva (efalizumab) was recommended for approval Sept. 9 by FDA's Dermatologic & Ophthalmic Drugs Advisory Committee (⁷ Also see "Raptiva Labeling Should Require Monitoring For Thrombocytopenia – Cmte." - Pink Sheet, 22 September, 2003., p. 27). The biologic's user fee deadline is Oct. 23.

October User Fee Lineup Includes 7 NMEs; Many Expect “Approvable” Action

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