The latest set of opinions from the European Medicines Agency includes a recommendation for Almirall’s irritable bowel syndrome therapy and backing for expanded approval for Pfizer and Bristol-Myers Squibb’s Eliquis for stroke.
First up, the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Almirall’s Constella (linaclotide) for the treatment of moderate to severe IBS with constipation in adults. It is the first drug to get a thumbs-up for IBS in Europe and the recommendation comes less than a couple of months after the US Food and Drug Administration for the treatment, sold across the pond by Ironwood Pharmaceuticals as Linzess.
The CHMP has also adopted a positive opinion for Leo Pharma’s Picato (ingenue mebutate) for actinic keratosis and backed expanding the use of a number of already-marketed drugs.
The most striking of those has been a recommendation for Pfizer/B-MS’ Eliquis (apixaban) to be used for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation, with one or more risk factors, such as prior stroke or transient ischaemic attack. The drug is already approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgery.
The latest recommendation for Eliquis proposes that apixaban should be contraindicated in patients at high risk for major bleeding and in patients receiving other anticoagulants. The stroke indication is potentially a lucrative one and Eliquis will be competing with Boehringer Ingelheim’s Pradaxa (dabigatran) and Bayer/Johnson & Johnson’s Xarelto (rivaroxaban).
The EMA’s advisors also backed Roche’s blockbuster Avastin (bevacizumab) in combination with the chemotherapies carboplatin and gemcitabine for the treatment of women with first recurrence of platinum-sensitive ovarian cancer. They also issued a positive opinion on Eli Lilly’s erectile dysfunction drug Cialis (tadalafil), for the treatment of benign prostatic hyperplasia.
The CHMP also issued positive opinions to expand the use of a number of diabetes drugs, such as AstraZeneca/B-MS’ Komboglyze (saxagliptin/metformin), Boehringer and Lilly’s Trajenta (linagliptin) and Novartis’ Galvus (vildagliptin) and Eucreas (vildagliptin/metformin).
Staying with Novartis and the CHMP backed the firm’s Votubia (everolimus) for renal angiomyolipoma associated with tuberous sclerosis complex (TSC).
