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Executive Summary

Antimicrobial and antihypertensive NDAs account for more than a third of the 47 pending new molecular entities filed during the five-year period ending Dec. 31, 1990, according to the most recent FDA "Offices of Drug Evaluation: Statistical Report." Of the 47 pending NMEs filed in the five-year period, 10 were NDAs for antimicrobials and seven were NDAs for antihypertensives. So far in 1991, FDA advisory committees have recommended for approval three of the 10 pending antimicrobials -- Astra's Foscavir (foscarnet), Abbott's clarithromycin and Pfizer's Zithromax (azithromycin). Foscavir was approved on Sept. 27, and the latter two have received "approvable" letters from FDA. The large number still pending is due, in part, to the fact that six antimicrobial NDAs were filed in 1990 alone out of a total of 19 NME NDAs submitted. In the antihypertensive group, FDA has made a significant dent in the group of 11 NDAs that were pending at the beginning of 1991 by issuing four approvals (see chart, next page, for list of 1991 NME approvals). The approval time for the four ranged from 27 to 41 months, with an average review time of 33.5 months. All of the pending antihypertensive NDAs were filed during the 1987-1989 period. Of the remaining seven antihypertensives, Pfizer's Norvasc (amlodipine) and Bristol-Myers Squibb's Betapace (sotalol) have been recommended for approval by FDA advisory committees. Betapace, a beta blocker, was listed by FDA in its survey as an antihypertensive. Bristol-Myers, however, has been developing the drug primarily as an anti-arrhythmic. The approach of the drug to marketing clearance was apparently signalled recently by the BMS announcement of the market withdrawal of Enkaid ("The Pink Sheet" Sept. 23, T&G-4). The changes in anti-arrhythmic treatment taking place because of the 1989 CAST trial results are creating an opening for new classes of anti-arrhythmics. From the group of NDAs filed in 1986-1990, there were 58 new molecular entity NDAs pending at FDA at the beginning of 1991; 11 NME NDAs subsequently have been approved, and at least 14 have been reviewed by advisory committees, resulting in 11 recommendations for approval. If FDA finishes its review of 12 or more NME approvals by the end of the year, it will surpass its total of NME approvals in 1990 and 1989, when 23 NMEs were approved. Upcoming advisory committee reviews include Boots' Manoplax (flosequinan) and Glaxo's Imitrex (sumatriptan injectable), scheduled for Oct. 24 and 25, respectively. An AIDS NDA filed earlier this year, Bristol-Myers Squibb's Videx (ddI), is reportedly set for approval imminently. BMS submitted the application for the product on April 2 and went to an advisory committee in mid-July. Center for Drug Evaluation and Research Deputy Director Gerald Meyer discussed FDA's approval track record at a Sept. 23 Parenteral Drug Association/FDA Joint Conference, asserting that the agency is "making real progress in the speed with which we can review applications in a given year." Meyer cited two factors contributing to speedier reviews: "a very significant improvement in the quality of applications received" and a 100% increase in the number of medical review officers over the past five years -- 140 in 1991 compared to 72 in 1987. He pointed to the number of approvals issued within 15 months of submission: six each in 1989 and 1990 and two so far this year. The average 1990 approval time for NMEs was 27.7 months, compared to 32.5 months in 1989. For the seven "1A" drugs approved in 1990 (important therapeutic gains over currently marketed drugs), FDA moved at a quicker pace with an average approval time of 16.4 months, an improvement over the year-earlier average of 22 months. The average approval time for 1991 actions will be elongated by FDA's clearance of the Wyeth-Ayerst NSAID Lodine (etolodac) in late January. The drug had been pending since 1982. Drug classes with three pending NDAs each include antihistamines, diagnostic agents, radioactive diagnostics and hormones. The enzyme inhibitor category, with two NDAs pending, has not fared well in 1991. Both Warner-Lambert's Cognex (tacrine) and Miles Glucobay (acarbose) failed to receive advisory committee approval at meetings this year. Antihistamines had better luck with the advisory committee determination that Schering-Plough's Claritin (loratadine) and Pfizer's Reactine (cetirizine) were "not likely" to be carcinogenic in humans, thus apparently clearing the way for the new entries in the non-sedating antihistamine class. Chart omitted.

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