Several drug companies received nods of support for getting their prized drugs approved for the European market. The Committee for Medicinal Products for Human Use (CHMP) revealed its recommendations today, with positive news for Amag Pharmaceuticals ($AMAG), AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Novartis ($NVS), Incyte ($INCY), and Takeda Pharmaceutical.
The CHMP backed AZ and BMS's dapagliflozin for approval to treat Type 2 diabetes, after the FDA shot down the companies' bid to gain an OK to sell the drug in the U.S. in January because of regulators' safety concerns about the program. The EU committee, however, noted the need for new diabetes drugs, citing the World Health Organization's estimate last year that 346 million people worldwide have the disease, which often leads to serious health problems such as cardiovascular disease.
Incyte and Novartis got more good news for the companies' JAK inhibitor known as INC424, with the CHMP pushing for approval of the drug in the EU for treating a blood cancer known as myelofibrosis. Incyte, which controls U.S. marketing of the drug, grabbed FDA approval for the product in November. Patients with the disease have few treatment options, giving the drug a leg up with regulators.
Amag and Takeda scored the CHMP's backing for the drug ferumoxytol for treating anemia in patients with kidney disease. Takeda is taking the lead on European development of the drug, which it plans to sell under the name Rienso.
- see the CHMP release
- here's Novartis' release
- check out the Reuters report on dapagliflozin