The latest set of opinions from the European Medicines Agency have brought plenty of good news for a number of drugmakers – Bayer, AstraZeneca and Takeda to name just three – and a recommendation for a new class of antibiotic.
First up, the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of the first antibiotic in a new class to treat infections with Clostridium difficile, Optimer Pharmaceuticals and Astellas’ Dificlir (fidaxomicin). It is a first-in-class macrocyclic antibiotic, which was approved in the USA in May, and the EMA says it “promises to improve current treatment of the inflammation of the gut and severe diarrhoea caused by C. difficult”. The agency adds that the potential cost of the infection per year in the European Union has been estimated to be as high as 3 billion euros.
Other new medicines recommended for approval are AstraZeneca/Bristol-Myers Squibb’s once-a-day diabetes pill Komboglyze, which combines the firms’ Onglyza (saxagliptin) with metformin, and Takeda’s Edarbi/Ipreziv (azilsartan medoxomil), a once-daily oral therapy for hypertension. There were also positive opinions for two other blood pressure combos, Boehringer Ingelheim’s Onduarp (telmisartan/amlodipine) and Novartis’ Rasitrio (aliskiren/amlodipine/hydrochlorothiazide) and two new HIV drugs – Johnson & Johnson’s Edurant (rilpivirine) and Gilead Sciences’ Eviplera (emtricitabine/ rilpivirine/tenofovir).
The CHMP has also given positive opinions about extending the indication on a couple of cancer treatments – Eli Lilly’s Alimta (pemetrexed) and Roche’s Avastin (bevacizumab) – and Novo Nordisk’s diabetes treatment Levemir (insulin detemir). It also recommends extending approval for Pfizer’s pneumococcal conjugate vaccine Prevenar 13 and Alexion’s Soliris; the latter has also just been approved by the US Food and Drug Administration for atypical haemolytic ureic syndrome (aHUS), a rare paediatric blood disorder.
Two recommendations for Xarelto
However, arguably the most significant expansion is for Bayer’s bloodthinner Xarelto (rivaroxaban). Specifically, the CHMP has recommended the drug for approval for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, as well as for the treatment of deep vein thrombosis and prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults.
Xarelto is already approved for the prevention of venous thromboembolism in patients undergoing elective hip or knee replacement surgery. If given the green light, the drug, which received the backing of an FDA advisory panel earlier this month for stroke prevention, will compete with Boehringer Ingelheim’s Pradaxa (dabigatran) and Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban).
Other highlights from the CHMP included positive opinions for generics of Merck & Co’s antihistamine Clarinex (desloratadine), UCB’s antiepileptic Keppra (levetiracetam) and Takeda’s diabetes drug Actos (pioglitazone). The committee also confirmed that the benefit-risk balance of Celgene’s Revlimid (lenalidomide) remains positive when used in combination with dexamethasone to treat adults with multiple myeloma.
