FDA Delays Action On MedImmune's Rezield Despite Negative Panel Vote
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
In a surprise move, FDA has delayed action on MedImmune's Rezield (motavizumab), its second-generation preventive treatment for respiratory syncytial virus, even though the agency already has a vote against approval from an overwhelmingly negative advisory committee review three weeks earlier
|
In a surprise move, FDA has delayed action on MedImmune's Rezield (motavizumab), its second-generation preventive treatment for respiratory syncytial virus, even though the agency already has a vote against approval from an overwhelmingly negative advisory committee review three weeks earlier. MedImmune's parent company, AstraZeneca, announced that FDA had "reset" the action date for motavizumab from June 24 to Aug. 27. The company directed questions about the resetting of the action date to FDA, but the agency said it could not comment. On June 2, the agency's Antiviral Drugs Advisory Committee voted 14-3 against recommending approval of motavizumab. Panel members cited concern that motavizumab was associated with a higher rate of hypersensitivity reactions, but not superior efficacy, compared with MedImmune's current RSV product Synagis (palivizumab), the parent compound. The committee suggested MedImmune should conduct pre-approval superiority studies of motavizumab in sicker populations to see whether the agent confers an efficacy advantage over palivizumab that might justify the heightened risk of adverse events (1 (Also see "AstraZeneca's Rezield Might Itself Be Saved By Sicker Patients" - Pink Sheet, 2 Jun, 2010.)). Motavizumab was the focus of an FDA "complete response" letter in 2008 requesting MedImmune reanalyze data to determine whether inconsistencies in local RSV testing at clinical trial sites may have biased study results. Given the lopsided nature of the advisory committee's negative evaluation, a second "complete response" letter was expected. One possible explanation for the agency's delay may lie in the need for more time to investigate allegations, contained in a wrongful termination lawsuit against MedImmune, that challenge motavizumab study data integrity. That FDA extended the user fee goal date only two months, as opposed to the standard 90-day extension allowed for additional review time when further data are submitted, lends some credence to that possibility. Petrus Roelvink, former R&D director for MedImmune's Infectious Diseases Department, alleges he was fired for bringing attention to discrepancies in RSV sample screening in a motavizumab surveillance study (2 (Also see "Motavizumab's Data Integrity Worries Grow As FDA Shows Interest In Lawsuit" - Pink Sheet, 7 Jun, 2010.)). The alleged test discrepancies were not reported to FDA, Roelvink asserted. The lawsuit was filed in April and its existence was discussed briefly at the advisory committee meeting. Debra Birnkrant, director of FDA's Division of Antiviral Products, said the agency had not had an opportunity to discuss the allegations directly with the company. "We would like to understand further what the allegations mean and what the actual discrepancies are and just understand the whole situation a lot better. And once we have that information, we'll gladly share it with the advisory committee," Birnkrant said at the time. AstraZeneca's Senior VP for R&D Bahija Jallal told the committee the company was confident that the data presented in the BLA and to the panel were accurate and the lawsuit contained unsubstantiated allegations. - Sue Sutter ( 3 [email protected] ) |