GlaxoSmithKline Plc (GSK) and Theravance Inc. (THRX)’s lung drug Anoro Ellipta won the backing of a U.S. advisory panel as the companies strive to gain marketing approval of their new combination pill ahead of competitors.
The safety and efficacy data provide substantial evidence to support regulatory clearance of the treatment for chronic obstructive pulmonary disorder, advisers to the Food and Drug Administration voted 11-2 today in Silver Spring, Maryland. The FDA is expected to decide whether to approve the combination treatment by Dec. 18.
The companies, which won FDA clearance in May for Breo Ellipta, are trying 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 generate $1.4 billion in sales in 2017, according to the average of nine analysts’ estimates compiled by Bloomberg.
“The safety and efficacy of the drug has been adequately demonstrated,” Francis McCormack, a panel member and director of the Division of Pulmonary, Critical Care and Sleep Medicine at the University of Cincinnati School of Medicine, said after the vote. “We are in desperate need of additional options in this category.”
Panel members agreed the FDA should require post-market studies of Anoro on more severe COPD patients who weren’t included in original trials and to further assess what appeared to be imbalances in cardiovascular risk demonstrated in the trials.
The companies have proposed labeling that includes a warning for patients with cardiovascular disease. FDA staff members said Anoro showed strong efficacy in a report ahead of the meeting though they raised concerns patients may be at risk of cardiovascular issues.
London-based Glaxo and South San Francisco-based Theravance sought approval for two dose levels of Anoro, while the FDA only asked the panel to consider the lower one. The companies expect only one of the doses to be approved, Michael Aguiar, chief financial officer at Theravance, said in an interview.
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.
Advisers considered an Anoro dose of 62.5 micrograms of umeclidinium and 25 micrograms of vilanterol. Each ingredient works through different mechanisms to open airways.
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.
Glaxo and Theravance tested Anoro against Pfizer Inc. (PFE) and Boehringer Ingelheim GmbH’s Spiriva and vilanterol alone. Novartis AG (NOVN) 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. (FRX) and Almirall SA, as well as Boehringer Ingelheim and AstraZeneca Plc also are studying LABA/LAMA combinations.
Theravance said in April 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.
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