CHMP breathes new life into GSK, Teva and Novartis
The CHMP has given its backing to a number of new treatments for respiratory diseases, which include two from London-based GlaxoSmithKline.
The European Medicines Agency’s safety and efficacy arm the CHMP said four of the drugs recommended for approval were intended to treat the symptoms of chronic obstructive pulmonary disease (COPD), with another two for asthma and COPD.
Pharmafile reported last week that the body had given its recommendation for GSK and partner Theravance’s new COPD pill Anoro, but the British firm has also received backing for its second COPD treatment Incruse (umeclidinium).
Like Anoro, Incruse is a once-daily maintenance treatment for COPD, a disease caused predominately by long-term smoking.
GSK, a leader in respiratory medicine with its blockbuster treatment Seretide/Advair, will be buoyed by the green light for both treatments given that its big-selling drug is coming under generic pressure.
And it is not just GSK celebrating as Israeli drugmaker Teva also received the nod for a combination of budesonide and formoterol, delivered by its Spiromax multi-dose dry powder inhaler for the regular treatment of asthma, and for the symptomatic treatment of patients with severe COPD.
The fixed dose combination of the drugs, which have an anti-inflammatory effect in the lungs and which open the airways, was submitted under the names BiResp Spiromax and DuoResp Spiromax.
Novartis also saw its respiratory medicine Ulunar Breezhaler given a new marketing authorisation by the CHMP, rounding off a positive period for patients awaiting new treatments for respiratory disorders.
Outside of COPD and asthma Vokanamet (canagliflozin and metformin), a new treatment for type 2 diabetes from Janssen, was also given the go-ahead. Gilead’s hepatitis C pill Sovaldi (sofosbuvir) in combination with ledipasvir for ‘compassionate’ care.
The CHMP’s decisions are not final and must now be ratified by the European Commission, the resolution of which usually takes three months but is rarely challenged.