The US Food and Drug Administration (FDA) has approved intravenous therapy of Fennec Pharmaceuticals Inc. to prevent chemotherapy-induced hearing loss in children. The new therapy is called Pedmark.
The approval, posted on the website of the US FDA, allows it to be used to decrease the risk of ototoxicity in children aged over one month who have undergone chemotherapy by using the drug cisplatin.
The Cisplatin drug is mainly used to treat a range of cancers in children like bone, liver, and brain cancer, but can also cause permanent hearing loss. Pedmark therapy is now the only therapy approved to prevent cisplatin-induced hearing loss in the United States, with a growing number of patients opting for either hearing loss or cochlear implants.
This was the third attempt by Fennec to secure approval for the intravenous treatment. The US FDA had declined two times to approve the therapy, citing several deficiencies at the manufacturing facility of the company.
According to Fennec, around 10,000 children in Europe and the United States receive chemotherapy with cisplatin or similar types of drugs every year, and hearing loss mainly depends on the dosage and duration of the therapy.