By Anna Rose Welch, associate editor
In the news this week, the FDA recently approved the first immunotherapy for melanoma, as well as drugs for epilepsy and myelodysplastic syndrome. The FDA also cleared several drugs for new indications, QIDP status, and orphan drug status.
UCB Earns Approval For Vimpat
UCBs supplemental NDA for its epilepsy treatment Vimpat was awarded an approval from the FDA as a monotherapy for those 17 and older with epilepsy. The drug previously received approval as an adjunctive treatment. All formulations of the drug can be administered with a new single loading dose administration option, which also received a nod of approval from the FDA. Because of the drugs multiple formulation options (tablets, oral solution, or injectable), Vimpat has brought in a good chunk of change for the company: nearly 217 million euros in the first half of 2014. The company expects this new monotherapy approval will help boost sales.
Mercks Pembrolizumab Get FDA Thumbs Up
A new big player in the realm of cancer treatments is poised to hit the market and is expected to garner billions in sales. Mercks Keytruda, pembrolizumab, is an immunotherapy indicated for those suffering from melanoma who didnt improve following treatment with Bristol-Myers Squibbs immunotherapy drug, Yervoy. Keytruda will be the first PD-1 treatment to take its place in the U.S. market. This form of treatment has garnered attention from researchers and doctors because of its ability to shrink tumors and increase patient survival rates, while causing only manageable side effects. Analysts estimate that total cancer immunotherapy sales could be worth roughly $32 billion by 2025, with Mercks Keytruda raking in about $6 billion on its own. The drug is expected to go for $12,500 a month, Reuters reported.
Ipsens Somatuline sNDA Granted Priority Review
The sNDA Ipsen filed is for Somatuline Depot 120 mg injection for those with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The sNDA features the results of the CLARINET phase 3 study, which demonstrated the drugs ability to improve progression free survival in those suffering from the serious and rare GEP-NETs. The drugs Active Pharmaceutical Ingredient (API) is lanreotide acetate, which halts the secretion of several endocrine, exocrine, and paracrine amines and peptides.
Promedior Myelofibrosis Drug Named Orphan Drug
PRM-151, a recombinant form of an endogenous human protein, Pentraxin-2 (PTX-2), was named an orphan drug in the U.S. geared toward the 18,000 U.S. residents aged 61-66 with myelofibrosis. The drug has the potential to prevent and potentially reverse fibrosis, and in preclinical models, has shown anti-fibrotic activity in various forms of fibrotic diseasesincluding pulmonary and liver fibrosis and age-related macular degeneration. Indeed, PRM-151 currently holds orphan drug designations from the U.S. and EU for Idiopathic Pulmonary Fibrosis.
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FDA News Roundup: Merck, UCB, Pfizer, Ipsen, And More