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Sandoz Launches First Generic of Esbriet
Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
Sandoz has launched the generic pirfenidone, the first fully substitutable equivalent to Genentech’s Esbriet, to treat patients with idiopathic pulmonary fibrosis (IPF). IPF is a progressive rare disease with no cure, which causes irreversible lung scarring and makes it difficult to breathe. It primarily affects adults over age of 50 and is more common in men. About 140,000 Americans live with IPF.
The generic pirfenidone is immediately available via specialty pharmacies. It is available as an oral therapy with two dosages: 267 mg and 801 mg. Sandoz is offering a $0 co-pay program for eligible patients.
“We developed this medicine in-house and continue to build our expertise and infrastructure to support our long-term commitment to grow our respiratory portfolio.,” Keren Haruvi, president of Sandoz said in a press release.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
