GlaxoSmithKline (NYSE: GSK) and Theravance Inc.’s combination treatment for a lung disease that is the No. 3 cause of death in the U.S. showed strong efficacy at both doses the companies sought for approval, regulators said.
Studies found the once-daily inhaled therapy, called Anoro Ellipta, works against chronic obstructive pulmonary disorder, though missing data may limit the reliability of the findings, Food and Drug Administration staff said today in a report. An advisory panel is scheduled to discuss the drug Sept. 10, and the FDA is expected to decide by Dec. 18 on approval.
The companies, which won FDA clearance in May for Breo Ellipta, are racing to get Anoro Ellipta to market before other similar combination-ingredient drugs to treat COPD, an umbrella term for emphysema and chronic bronchitis. Anoro is expected to surpass $1 billion in sales in 2017, according to the average of nine analysts’ estimates compiled by Bloomberg.
While the FDA staff said the companies’ dosing for Anoro was reasonable, the agency only asked advisers to consider the lower dose sought for approval. Imbalances in data could also suggest a greater cardiovascular risk for Anoro, FDA staff said.
“When you think about success for us, we really only need one” of the doses, Michael Aguiar, chief financial officer at South San Francisco-based Theravance, said in an interview. “If we got one, that would be in line with our expectations. We did not file two expecting to get two.”
Anoro is a combination of vilanterol, a long-acting beta agonist or LABA, and umeclidinium, a long-acting muscarinic antagonist or LAMA, used with London-based Glaxo’s Ellipta inhaler. Breo’s active ingredient is vilanterol.
Glaxo and Theravance tested Anoro against Pfizer Inc. and Boehringer Ingelheim GmbH’s Spiriva and vilanterol alone. Novartis AG is researching a LABA/LAMA combination for COPD called QVA149. Basel, Switzerland-based Novartis said in July that it expects to file for U.S. approval at the end of 2014.
Forest Laboratories Inc. and Almirall SA, as well as Boehringer Ingelheim and AstraZeneca Plc also are studying LABA/LAMA combinations.
Dropout rates in Anoro studies on the drug’s effectiveness ranged from 15 percent to 33 percent, FDA staff said. The patients experienced improvement in lung function prior to their withdrawal and the effect was assumed after the patient stopped taking the therapy, an assumption staff called “implausible.”
FDA staff also noticed imbalances in heart safety trials, though they said the data didn’t show a clear link to Anoro or specific doses.
The companies sought approval for Anoro containing 125 micrograms of umeclidinium as well as 62.5 micrograms of the long-acting muscarinic antagonist. Both contain 25 micrograms of vilanterol, the same amount of the ingredient in Breo.
Breo combines vilanterol with a corticosteroid to open the airways and reduce inflammation. Anoro combines two bronchodilators that open the airways through different mechanisms. Breo is best for patients at risk of a worsening of the disease while Anoro is expected to be used on patients who complain they need to breathe better, Theravance Chief Executive Officer Rick Winningham said in an interview.
Breo is expected by analysts to have sales of $1.6 billion in 2017.
Theravance will earn tiered royalties of 6.5 percent to 10 percent on Anoro sales if the drug is approved, Aguiar said.
Theravance said last month it would split into two companies at the end of this year or early 2014. One of the companies will be called Royalty Management Co. and will focus on the Glaxo collaboration, while the other, Theravance Biopharma, will focus on developing drugs. Glaxo is the largest shareholder of Theravance with 27 percent of the stock.
Winningham and Aguiar expect to lead both companies in the beginning and end up long-term focusing on early-stage therapies at Theravance Biopharma, Aguiar said.
GSK operates its North American headquarters in Research Triangle Park, N.C.
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