Europe recommends GSK’s melanoma drug

GlaxoSmithKline has received EU approval for its new COPD treatment and a recommendation for its new melanoma drug – which is shortly to be transferred to Novartis.

The company’s new COPD treatment is Incruse (umeclidinium) is a once-daily, maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD).

Incruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator known as an anticholinergic. Incruse is a 55mcg strength inhalation powder delivered by the Ellipta inhaler.

The drug is also being combined in a 2-in-1 treatment with long-acting beta 2 adrenoreceptor agonist (LABA) vilanterol under the brand name Anoro, to create the first ever once daily COPD treatment.

Analysts predict peak sales in excess of £2 billion, and the drug combination gives GSK a follow-up product for its existing COPD blockbuster, Seretide/Advair.

The first launches of the drug in Europe are planned for before the end of 2014.

Melanoma drug – bound for Novartis

Meanwhile GSK has also just received a recommendation from the European Medicines Agency’s CHMP committee for Mekinist (trametinib), a single agent in the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation.

Trametinib as a single agent has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy, and therefore can only be used as a first line treatment. Patients must also be tested to confirm they have the BRAF V600 mutation before being given the drug.

Dr Rafael Amado, Head of Oncology R&D at GSK said: “This CHMP opinion brings us a step closer to making another personalised medicine available for patients with BRAF-mutant metastatic melanoma in Europe.”

A final decision by the EC is anticipated during the second quarter of 2014. The CHMP approval for Mekinist is particularly notable because it is part of the GSK oncology portfolio that will shortly transfer over to Novartis. Last week GSK and Novartis unveiled a groundbreaking multi-billion dollar deal in which Novartis has acquired GSK’s cancer portfolio – including all marketed products and late-stage candidates such as Mekininst – for $14.5 billion, with a further $1.5 billion dependent on milestones.


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