15 new medications headed toward EU approval
- The EU's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 15 new medicines, Pharma Times reports. The European Medicines Association (EMA) is currently starting the review process for these therapies.
- Among the 15 recommended medications are treatments for non small-cell lung cancer (NSCLC), hepatitis C (a new Gilead combo product), chemotherapy-induced neutropenia, and more.
- Three of the products are considered hybrid applications, including Teva’s budesonide/formoterol (a generic version of Symbicort) for treatment of asthma and severe chronic obstructive pulmonary disease (COPD).
This fall has been a particularly productive time for the CMHP. The 15 products under review are noteworthy for various reasons, and some of the most interesting candidates include Gilead’s Harvoni (sofosbuvir/ledipasvir) for treatment of hepatitis C; Janssen-Cilag’s Rezolsta (darunavir/cobicstat) for treatment of HIV; and Eli Lilly’s Trulicity (dulaglutide) for type 2 diabetes. The new Gilead combo could be yet another game changer for the firm, as it eliminates the need to take the blockbuster hep C drug Sovaldi in combination with ribavarin and interferon.
Two cancer treatments are also being reviewed -- Boehringer Ingelheim's Vargatef (nintedanib) for NSCLC and Eli Lilly's Cyamza (ramucirumab) for gastric cancer. There are a slew of other candidates that run the gamut from erectile dysfunction, to opioid-induced constipation, to various types of respiratory dysfunction.
You can view an overview of the EMA review process here.
- Pharma Times Fifteen medicines leap toward EU approval