More manufacturing issues: Fennec preps for second CRL for potential hearing loss drug
Shares of Fennec Pharmaceuticals stock were cut almost in half early Monday as the company said manufacturing issues caused another FDA rejection of its reformulated version of sodium thiosulfate, which is intended to help kids who lose hearing due to chemo treatment.
The biotech had resubmitted an NDA for the drug to treat platinum-based, chemo-related ototoxicity in young children earlier this year. The first NDA was denied by the FDA last year, with the agency citing manufacturing issues with the biotech’s supplier.
Again this morning, according to Fennec, the FDA identified unspecified deficiencies following a pre-approval inspection of the manufacturing facility that Fennec planned to use for the drug, to be known commercially as Pedmark. Once the official CRL is received, Fennec says it plans on requesting a follow-up meeting with the FDA to discuss next steps on a second resubmission.
At the time of the company’s first CRL on Pedmark, CEO Rosty Raykov told investors there were no clinical safety or efficacy problems and an additional trial was not required, but when pushed on the Form 483 the biotech received and what issues had to be resolved, Raykov demurred from the issue. That time, Fennec’s stock price fell more than 35%.
Pedmark received fast track designation from the FDA back in 2018 after two Phase III studies looked at the survival and reduction of ototoxicity in five pediatric cancers that typically require intensive treatment. Currently, there are currently no approved drugs that prevent ototoxicity, or hearing loss, in platinum-based chemotherapies. And patients who end up losing their hearing must typically opt for cochlear implants.