GlaxoSmithKline snags FDA approval for blockbuster COPD contender

GlaxoSmithKline ($GSK) and Theravance ($THRX) scored another victory through their profitable partnership, winning FDA approval for Anoro Ellipta, a trailblazing COPD combo therapy with billion-dollar potential.

The drug leads a new class of COPD treatments that combine a long-acting beta agonist (LABA) with a long-acting muscarinic antagonist (LAMA), and Anoro is the first once-a-day LABA/LAMA cocktail approved in the U.S., the partners said. The FDA's blessing vaults GSK and Theravance ahead of competitors like Novartis ($NVS) and Boehringer Ingelheim, and analysts expect Anoro's peak sales to land somewhere around $1.4 billion.

GSK will be the first mover in the LABA/LAMA space when it launches Anoro in the first quarter of next year, but the market looks like it's going to crowd in a hurry. Novartis is gearing up to file an NDA for the similar QVA149, and AstraZeneca ($AZN) made its big entrance into LABA/LAMA when it traded $1.2 billion for Pearl Therapeutics this year. Meanwhile, Boehringer and Almirall are developing combo drugs of their own with eyes on a 2015 launch.

But there may be room for more than one blockbuster: COPD affects about 27 million people in the U.S. alone, GSK says, and Citigroup estimates the market for treatments will soar from $10 billion this year to $14 billion in 2018.

Anoro's approval follows a May FDA nod for Breo Ellipta, a LABA drug, and GSK is counting on its two new treatments to ease the pain of lost sales from the soon-to-go-generic Advair, which brings in about $8 billion a year. The latest approval triggers a $30 million milestone payment for Theravance, and the company will get another $30 million when GSK commercializes the drug.

Anoro won an 11-2 vote of confidence from a panel of FDA advisers in September, with reviewers taking some issue with the drug's safety profile but applauding its efficacy. Like most LABA-containing drugs, Anoro will carry a boxed warning detailing the risks of asthma-related death, and its most common adverse events are headache, nasopharyngitis, cough, upper respiratory tract infection and back pain, according to GSK.

- read the announcement

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