FDA view on COPD drug positive for Theravance

Markus MacGill


The COPD drug combination known as Breo in the US and Relvar in Europe (fluticasone and vilanterol) has given mixed results but is seen as positive for Theravance, whose share price has surged.

Theravance is based in South San Francisco and has partnered with Britain’s GlaxoSmithKline on the clinical development of this treatment.

The better-than-expected view of US regulators has impressed investors, who had feared safety surprises or concerns about dose selection. Theravance shared leapt by 17.4 per cent.

“The FDA review is benign and a relief, given the issues that emerged in this clinical trial programme.”

Alistair Campbell, analyst at Bernberg Bank.

“In addition to strong positive implications for the upcoming panel, we believe the briefing document essentially eliminates the worst-case scenario that dose selection of vilanterol is questioned or if there is a safety surprise which could negatively affect GSK’s other filings such as Anoro”

Howard Liang, analyst at Leerink Swann.

If approved, Breo would compete with, or replace, another of GlaxoSmithKline’s COPD drugs, the twice-daily option Advair (fluticasone and salmeterol), and also AstraZeneca’s Symbicort (budesonide and formoterol).

The FDA advisory committee will meet to discuss the drug on Wednesday, April 16, and a final decision is due by May 12.



Related news:

FDA review of Glaxo/Theravance lung drug seen as positive (Reuters)

Theravance rallies after FDA’s mixed Breo briefing (FierceBiotech)

Reference links:

Theravance respiratory pipeline

US Food and Drug Administration

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