FDA’s IMPORTANT THERAPEUTIC BIOLOGICS AVERAGE REVIEW TIME IS 35 MONTHS IN 1992

The average review time for important new therapeutic biologic products approved in 1992 is 35 months. The list of important new biologic approvals prepared by FDA's Center for Biologics Evaluation and Research includes four therapeutic biologic products, an NDAed product, one new therapeutic indication for a previously approved biologic, two vaccines and two allergenic extracts (see chart p. 12). In addition, three in vitro diagnostics were approved during the year that FDA considers "important." All were HIV test kits. FDA issued a total of 67 biologic licenses in 1992. The agency reports that 721 license amendments were accepted, an increase from the 507 in 1991, and 127 licenses were revoked, withdrawn, inactivated or denied. CBER cleared the first standardized cat extracts for the diagnosis and treatment of allergies to cats. In January of last year, the agency required that nonstandardized cat extracts be removed from the market. Approved on Sept. 24, the extracts include Miles' standardized cat hair and pelt, Ohio-based Allergy Laboratories and Greer Laboratories' standardized cat hair products and EM Industries' standardized cat pelt product. Connaught received approval for the second acellular pertussis vaccine Tripedia in August, eight months following the FDA clearance of Lederle's accellular pertussis vaccine Acel-Imune. Despite the delay, Connaught won an exclusive one-year federal supply contract from the Centers for Disease Control and Prevention in November for Tripedia over the Lederle product. Connaught also will be supplying the U.S. government with JE-VAX, which was approved in mid-December. The Japanese encephalitis vaccine made by Biken in Japan will be used primarily by U.S. troops and tourists traveling in Asian countries. Two therapeutic blood disorder products considered to be important biologics were cleared by FDA in 1992. Baxter/Genetic Institute's recombinant antihemophilic Factor (VIII) Recombinate received approval in December ahead of Miles' KoGENate, which is still pending even though Miles submitted the PLA for its recombinant product one year before Baxter. Miles said it expects approval for KoGENate shortly, possibly in January. The first monoclonal antibody-purified Factor IX product, Armour's Mononine, was approved in August as a replacement therapy for patients with hemophilia B. Early in the year, Chiron received approval for its long- awaited and controversial metastatic renal cell carcinoma product Proleukin (interleukin-2). In mid-July, CBER cleared Schering's Intron A for the additional indication of treatment of patients with chronic hepatitis B. The center concluded the year with the late December approval of another important oncologic product, Cytogen's OncoScint CR/OV, the first monoclonally-based imaging agent for known or recurring colorectal and ovarian cancers. An NDA for Amersham's Indiclor (Indium 111 chloride), the radioisotope that is linked to the OncoScint monoclonal antibody, was approved simultaneously. Chart omitted.