Ten new medicines – including a stream of respiratory drugs – have taken a giant leap closer to breaking into the European market after advisors backed their approval.
The Committee for Medicinal Products for Human Use (CHMP) has endorsed issuing marketing authorisations for six medicines for the treatment of respiratory diseases.
Four of these – GlaxoSmithKline’s Anoro (umeclidinium bromide/vilanterol), Laventair (umeclidinium bromide/vilanterola and Incruse (umeclidinium bromide) and Novartis’ Ulunar Breezhaler (indacaterol/glycopyrronium bromide) – are all waiting in the wings to treat symptoms of COPD in adult patients.
The others – Teva’s DuoResp Spiromax (budesonide/formoterol) and BiResp Spiromax (budesonide/formoterol) – are intended for the treatment of asthma and COPD.
Elsewhere, Pregabalin Pfizer bagged a thumbs up for the treatment of neuropathic pain, epilepsy and general anxiety disorder, BioMarin’s orphan drug Vimizim (elosulfase alfa) for the treatment of the rare genetic disorder mucopolysaccharidosis type IVA, and Johnson & Johnson’s Vokanamet (canagliflozin/metformin) for the treatment of type 2 diabetes.
The CHMP also recommended a paediatric-use marketing authorisation (PUMA) for Pierre Fabre’s Hemangiol (propranolol) for the treatment of proliferating infantile haemangioma, abnormal growths involving blood vessels that develop in the skin or internal organs.
This is only the second time that a positive opinion for a PUMA has been granted since the scheme – under which medicines are approved specifically for children – was introduced in 2007.
