UPDATE: GSK gets positive rulings on shingles, asthma treatments
Source - SMW
GlaxoSmithKline has received favorable rulings from European regulators regarding two separate treatments, one for shingles and the other for asthma.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorisation for Shingrix, a vaccine for the prevention of shingles.
The treatment can also be applied to post-herpetic neuralgia, the most common and often painful shingles-related complication in adults aged 50 years or older.
"Shingles is a painful and potentially serious condition," chief medical officer for GSK vaccines, Thomas Breuer, said.
"The risk of developing shingles increases with age and it is estimated that around one-in-three people will develop shingles in their lifetime."
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the commission was anticipated in April 2018, GSK said.
In a separate ruling, the CHMP also recommended a label update for the use of once-daily Relvar Ellipta, an inhaled corticosteroid for treating patients with asthma.
"We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients," GSK senior vice-president and global head of respiratory franchise Jonathan Sweeting said.
GSK said a final decision on marketing authorisation was anticipated towards the end of the first quarter.
At 1:16pm: (LON:GSK) GlaxoSmithKline PLC share price was +17.2p at 1352.2p