The latest set of opinions from the European Medicines Agency includes recommendations for AstraZeneca's antibiotic Zinforo and Novartis and Vectura's new smoker's cough drug.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Zinforo (ceftaroline fosamil), a new intravenous cephalosporin antibiotic for the treatment of adults with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP). AstraZeneca said the drug is the first monotherapy antibiotic "to combine the established tolerability of the cephalosporin class, with effective coverage of a range of bacteria responsible for serious skin infections and pneumonia", including difficult to treat strains such as methicillin-resistant Staphylococcus aureus in cSSTI and Streptococcus pneumoniae in CAP.
The Anglo-Swedish drugmaker's R&D chief Martin Mackay said “we remain one of the few companies still committed to novel antibiotic research, with one of the world’s largest antibacterial pipelines and many strong partnerships to address this significant unmet medical need". Zinforo is licensed from Forest Laboratories and the latter launched the drug, as Teflaro, in the USA in March 2011.
The CHMP has also recommended approval of Novartis' Seebri Breezhaler (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) licensed from the UK's Vectura and Japan's Sosei, for the treatment of chronic obstructive pulmonary disease. Stefan Hamill, an analyst at Peel Hunt, said the positive opinion "is a ringing endorsement" of the drug's once-daily profile, and when launched it will be the second-to-market once-daily LAMA after Boehringer Ingelheim/Pfizer's blockbuster Spiriva (tiotropium).
Less good news came for Pfizer and Protalix BioiTherapeutics new treatment for Gaucher disease Elelyso (taliglucerase alfa). The CHMP gave a positive risk-benefit assessment on the drug but could not recommend marketing authorisation, due to Shire's rival product Vpriv (velaglucerase alfa) which was approved for the same indication in August 2010 and was granted ten-year exclusivity.
Another highlight of the meeting saw backing for Sanofi's Hexaxim to be used outside the European Union. The vaccine is designed to protect infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b, including meningitis.