U.S. FDA approves Fennec's hearing loss therapy

Fennec Pharmaceuticals

21/09/2022 11:05

Sept 21 (Reuters) - The U.S. Food and Drug Administration
has approved Fennec Pharmaceuticals Inc's  FENC.O  intravenous
therapy to prevent chemotherapy-induced hearing loss in
children, according to the health regulator's website.
    The approval, posted on the regulator's website late
Tuesday, for Pedmark allows it to be used to reduce the risk of
ototoxicity in children aged over one month who have undergone
chemotherapy using the drug cisplatin.
    Cisplatin is used in treating a range of cancers in children
such as liver, bone and brain cancer, but can cause permanent
hearing loss. 
    Pedmark is now the only approved therapy to prevent
cisplatin-induced hearing loss in the United States, with most
patients opting for either cochlear implants or hearing aids.
    The company's shares closed nearly 16% higher on Tuesday. 
    This was Fennec's third attempt to secure approval for the
intravenous treatment. The FDA had twice declined to approve the
therapy citing some deficiencies at the company's manufacturing
facility.
    According to Fennec, nearly 10,000 children in U.S. and
Europe receive chemotherapy with cisplatin or similar drugs each
year, and the incidence of hearing loss depends on the duration
and dosage of the therapy.    

 (Reporting by Raghav Mahobe and Mrinalika Roy in Bengaluru;
Editing by Dhanya Ann Thoppil)
 ((Raghav.Mahobe@thomsonreuters.com;))