When Europe’s drug approval gatekeepers meet, they often tick off recommendations for some key Big Pharma products. This week, the Committee for Medicinal Products for Human Use backed a whopping 15 new meds and 3 new indications.
That’s more than one-quarter of the approvals they’ve issued this year, the CHMP helpfully pointed out in its wrap-up of decisions. Predictably, the pharma press releases went flying. Here are some of the highlights. You can find the entire list here.
– Eli Lilly got a double dose of good news: The committee backed Cyramza (ramucirumab), its star oncology prospect, for an orphan use in gastric cancer. It was approved by the FDA for the same use in April, and, armed with new data released earlier this month, Lilly plans to seek FDA’s blessing for colon cancer early next year.
– Lilly also won CHMP’s blessing for Trulicity (dulaglutide), its diabetes treatment that’s ready to compete head-to-head in the GLP-1 market with Novo Nordisk’s Victoza. As a long-acting injection, Trulicity has convenience on its side, and Lilly is hoping to turn that advantage into blockbuster sales.
– Gilead Sciences nabbed CHMP backing for its new hepatitis C combination pill Harvoni (sofosbuvir plus ledipasvir). Up for an FDA decision next month, Harvoni is expected to follow in the footsteps of Sovaldi (sofosbuvir on its own), churning out sales by the billion on a price of almost $100,000 per course.
– AstraZeneca managed a double win, too. Its new constipation drug for patients using opioid painkillers, Moventig, got the committee’s thumbs-up. The brand-new med–approved by FDA just last week under the brand name Movantik–is the first in a round of new drugs for the condition.
– AstraZeneca also will benefit from the CHMP’s recommendation on Brimica Genuair (aclidinium bromide plus formoterol fumarate), filed by Spain’s Almirall, to treat chronic obstructive pulmonary disease (COPD). AZ recently agreed to buy a portfolio of respiratory drugs from Almirall, including Brimica Genuair. It’s part of AZ’s efforts to rebuild a respiratory franchise after rivals to its blockbuster Symbicort erode sales.
– Boehringer Ingelheim picked up an approval in oncology. Vargatef (nintedanib) won the CHMP green light as a treatment for non-small cell lung cancer. It’s not yet approved by the FDA, but the agency gave it the coveted “breakthrough” designation to speed it on its way to a decision for a blockbuster-potential use, to treat idiopathic pulmonary fibrosis.
– Teva Pharmaceutical Industries got CHMP’s backing for a copycat version of AstraZeneca’s Symbicort, to treat COPD and asthma. The drug itself–budesonide plus formoterol–won a recommendation. And key to its launch, its delivery device did, too. So, Vylaer Spiromax could soon be a go.
We’ll leave you to check out the CHMP’s release for its opinions on broader use of Novartis’ Cushing’s disease drug Signifor, AstraZeneca’s lung cancer drug Iressa and Johnson & Johnson’s antiviral Prezista.
By Tracy Staton