The FDA dealt another blow to Fennec Pharmaceuticals' attempt to market a drug to treat hearing loss in pediatric cancer patients. The agency issued a second complete response letter targeting manufacturing issues.
Following a recent preapproval inspection of its manufacturing facility, the regulatory agency noted “deficiencies have been identified” at the site, the company said. Details of the manufacturing problems weren’t disclosed, and Fennec said it will request a meeting with the agency once the official CRL is received.
In August 2020, the FDA declined to approve Pedmark for similar reasons. At the time, Fennec resubmitted its application, and the agency set a target action date of Nov. 27 to reach a decision. Pedmark is Fennec’s only clinical drug candidate in its pipeline.
Pedmark, which is administered intravenously, targets children one month to 18 years of age who have undergone platinum-based chemotherapy that uses cisplatin. Although common for use in treating a range of cancers in children, the therapies can cause permanent hearing loss. Fennec has said two late-stage studies of Pedmark, which are also under review by the European Medicines Agency, indicated a reduction of cisplatin-induced hearing loss in children with various cancers such as liver, bone and brain cancer.
More than 10,000 children in the U.S. and Europe may be treated with platinum-based chemotherapy, the company said. There are no approved therapies to prevent cisplatin-induced hearing loss in the U.S.