Berlex Disappointed by Dismissal of FDA Lawsuit.CEDAR KNOLLS, N.J.--(HealthWire)--Oct. 8, 1996--Berlex Laboratories is disappointed that the court has dismissed the company's lawsuit against the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the approval of Biogen's interferon beta-1a interferon beta-1a Avonex, Rebif Pharmacologic class: Biological response modifier Therapeutic class: Antiviral, immunoregulator Pregnancy risk category C Action(Avonex(TM)).In making his ruling, the judge acknowledged that Avonex has not been tested in controlled clinical trials controlled clinical trial, n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo. in multiple sclerosis (MS) patients. Judge Robertson writes, "FDA conceded that it had never before approved a new biological drug on the basis of a clinical study of a `comparable' drug..." Dr. Jeffrey Latts, vice president for Clinical R&D at Berlex commented that, "The scientific basis for demonstrating the equivalence of two biological therapies is unclear. In this context, accepting equivalency without requiring controlled clinical trials is an unprecedented action by the FDA, which, from a scientific perspective, leaves uncertainty regarding the safety and efficacy of Avonex." In his ruling on an admittedly technical legal point, the judge allowed to stand an FDA decision that voided void·ed adj. Heraldry Having the central area cut out or left vacant, leaving an outline or narrow border: a voided lozenge. the orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the protection granted to Berlex's product, Betaseron(R). Although Betaseron has demonstrated unsurpassed safety and efficacy in the treatment of multiple sclerosis, a small difference in side effect profile was deemed sufficient to overturn orphan drug protection. "We believe this is an unfortunate outcome for patients with uncommon medical conditions such as multiple sclerosis," said Howard Robin, corporate vice president of Berlex Laboratories. "Given the ease with which the Orphan Drug Act can be overturned, patients with rare diseases may see fewer new therapies in the future." Berlex will continue to explore with Rentschler Biotechnologie various approaches to bring Rentschler's clinically-validated Beneferon(TM) to the U.S. market. Berlex remains confident that the marketplace will continue to recognize the overwhelming superiority of the scope and depth of the clinical data for Betaseron. Only Betaseron has been clinically studied in different strengths and has unsurpassed results in reducing brain lesions as measured by MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. . Berlex Laboratories is committed to bringing innovative programs to support the care of patients with multiple sclerosis. CONTACT: Wendy Neininger (201) 292-8043, or Dr. Jeffrey Latts (510) 262-5036 of Berlex Laboratories |
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