GlaxoSmithKline Drug Closer to European Approval

GlaxoSmithKlineEuropean regulating authorities have announced approval on Thursday to GlaxoSmithKline for a Chronic Obstructive Pulmonary Disease drug which they developed in conjunction with Threavance, named Anoro, to advance into the final stages of the approval process.  The Committee for Medicinal Products for Human Use, part of the European Medicines Agency, gave its recommendation to allow marketing  of umeclidinium/vilanterol. Anoro is the name the drug will be sold under. GlaxoSmithKline also continued to lobby on behalf of its other product lines.

British pharmaceutical company GlaxoSmithKline, is the world’s fourth-largest pharmaceutical company. It partnered with San Francisco based Theravance to develop the COPD drug, currently referred to as Anoro.

COPD is a generic term used to describe progressive lung diseases. These include various respiratory ailments such as severe asthma and emphysema. Smoking is listed as a major cause of COPD and shortness of breath is a common symptom. The American Lung Association reports that as of 2011, at least 12 million Americans have the condition, but the number could be as high as 24 million due to misdiagnosis. Actor Leonard Nimoy, known for playing Mr. Spock on the Original Star Trek series, is among the most recent celebrities to announce that he has COPD.

Typically, garnering a favorable disposition from the committee is followed by a final approval to market the product by the European Commission. GlaxoSmithKline and Theravance said that they expected to decide by the time the second quarter was over. According to Patrick Vallance, in charge of Pharmaceuticals Research and Development, the drug has been brought one step closer to reaching people suffering from COPD.

The United States (US) government approved Anoro Ellipta  for use treating US patients with airflow obstruction issues for GlaxoSmithKline last year. Canada also authorized the drug in 2013.

GlaxoSmithKline researchers recommend following a close combination of umeclidinium/vilanterol and Ellipta once daily to alleviate COPD symptoms in adult patients. The drug is a combination of UMEC, a long-acting muscarinic antagonist, and VI, a long-acting beta agonist. The drug is administered via inhaler. According to a poll by Thomson Reuters, once the drug is approved in Europe, it should generate over $2 Billion in revenue by 2018.

While GlaxoSmithKline pushes European authorities for approval of its latest drug, it still advocates greater government prevention and control of pharmaceutical products it does not make. GlaxoSmithKline does not manufacture a version of the latest smoking-cessation product known as electronic cigarette (e-cigarette). Instead it sells its long-standing nicotine gum. GlaxoSmithKline advocates for listing e-cigarettes as medicine, making them harder to purchase. Meanwhile the British pharmaceutical giant has fought legislation against its smoking-cessation products. In 2011, it moved to block recommendation against long-term use of its nicotine gum.

The news of Anoro’s latest approval has had positive impact on GlaxoSmithKline stocks. The company’s shares increased by. 0.65 percent today. However, Theravance shares dropped by once percent.

GlaxoSmithKline and Theravance appear close to having the drug Anoro approved in Europe by July of this year. The European medical authorities have given it positive reviews, and it seems to perform well in North America. To date there are no major concerns with the drug’s use. If the predictions from Thomson Reuters prove correct, the drug will be a success for the two pharmaceutical companies.

By Ian Erickson

Sources:
COPD Foundation
FiercePharma
Fox Business
Reuters

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