Two CRLs later, FDA endorses drug to prevent hearing loss associated with chemo
After rejecting it twice, the FDA has finally approved a new drug for lowering the risk of hearing loss among children being treated for cancer with chemotherapy.
Pedmark, as Fennec Pharma calls its drug, is a formulation of sodium thiosulfate. Given that ototoxicity is a major dose-limiting side effect of cisplatin chemotherapy and there were no available treatments for it, the FDA granted North Carolina-based Fennec both fast track and breakthrough therapy designations back in 2018, and put the drug on priority review two years later.
But manufacturing issues that turned up at a pre-approval inspection and were documented in a Form 483 ultimately led to a complete response letter from the FDA. A resubmission one year later failed to change the FDA’s minds.
Then this April, Fennec filed for approval a third time.
In its recent quarterly report, the company noted that it’s built out the commercial organization over the past months with key hires in sales, market access and field-based medical teams.
Pedmark is indicated for pediatric patients between 1 month to 18 years old who have localized, non-metastatic solid tumors and have been treated with cisplatin infusions for no longer than six hours. For this group of patients, hearing loss stemming from such chemotherapies is often long-lasting and permanent, and currently they would need to resort to cochlear implants.
Common side effects include hypersensitivity, hypernatremia (having too much sodium in the blood), hypokalemia (having too little potassium), nausea and vomiting.
Shares $FENC rose almost 16% to $7.63.
