Nucala receives approval from US FDA

GlaxoSmithKline plc received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala^® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. It is administered as a 100mg fixed dose subcutaneous injection every four weeks. Patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and may include oral corticosteroids.

GlaxoSmithKline will Set Up New Manufacturing Unit

UK based drug major GlaxoSmithKline began work for setting up a Rs 1000 crore pharmaceutical manufacturing unit in Karnataka, India. Karnataka Chief Minister Siddaramaiah laid the foundation stone in the presence of UK's Minister of State for Trade and Investment Francis Maude.

It will be fully operational in 2017 and will make more than 8 billion tablets and 1 billion capsules for the Indian market. The facility will be built on a 50-acre site in Vemgal, it said. The facility will also include a warehouse, employee welfare center and utilities to support the manufacturing and packing of medicines.

The Managing Director of company Annaswamy Vaidheesh said in a statement that GSK  has been at the forefront of serving the healthcare needs of India for more than 90 years. H added "We fully support the Government in their efforts to increase access to affordable medicines to improve healthcare and we are very excited to begin work on what will become our largest manufacturing facility in India."

Breo Ellipta inhaler Trial Fails to Show Extension of Life

UK based Pharmaceutical firm GlaxoSmithKline PLC has failed to show that the company’s Breo Ellipta inhaler extends life in patients with chronic obstructive pulmonary disease, dashing hopes of a sales boost for the product. Glaxo had hoped that the so-called Summit study, which tested Breo against a placebo in 16,485 patients from 43 countries, would demonstrate that the product prolonged life as well as helped with breathing.

Summit was the first study to test the effect on survival of inhaler products like Breo, which open up the airways to ease breathing in patients with asthma or COPD. It enrolled patients at higher risk of cardiovascular disease to see if Breo could bring added survival benefits to this group. About half of the people diagnosed with COPD are at heightened risk of cardiovascular disease.

The company said patients on Breo were 12.2% less at risk of dying than those on the placebo, but the difference wasn’t large enough to be significant. The drug also reduced the rate of lung infections and heart problems, but Glaxo said it couldn’t draw any solid conclusions from those secondary studies.

Still, the results are a blow to Glaxo. A positive result could have boosted sales of Breo by encouraging doctors to prescribe the drug over others in patients with higher cardiovascular risk. Breo is one of the drugs Glaxo is betting on to increase sales as its older blockbusters lose patent protection, but the drug’s market share hasn’t grown as quickly as expected because U.S. insurers have been slow to cover the drug.

Breo was launched in the U.S. in 2013 as a treatment for COPD. It later won approval from the Food and Drug Administration for use in adults with asthma. In Europe, where the product is known as Relvar Ellipta, the drug is used for COPD and asthma.

Glaxo has become a lower-margin company following its $20 billion asset swap with Novartis AG, in which it traded its highly profitable oncology franchise for the Swiss company’s vaccines business, which has slimmer margins. The pair also formed a joint venture, controlled by Glaxo, for their over-the-counter medicines, which also have lower margins than prescription pharmaceuticals.