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Gilead's Letairis Gets FDA Nod in Combination with Adcirca

Gilead Sciences, Inc.GILD announced that the FDA has approved Letairis in combination with Eli Lilly and Company's LLY Adcirca (tadalafil) for reducing the risk of disease progression and hospitalization and improving exercise ability in patients suffering from pulmonary arterial hypertension (PAH) (WHO Group 1).

Both Letairis and Adcirca are approved in the U.S., EU and other countries as once-daily treatments for patients with PAH WHO Group 1 with WHO/NYHA functional class II and III symptoms as single agents.

It was found that the combination of Letairis and Adcirca as a first-line treatment reduced the risk of disease progression by nearly 50% in PAH patients with WHO functional class II-III symptom, compared to Letairis and Adcirca alone.

We note that Gilead commercializes Letairis in the U.S., while GlaxoSmithKline plc GSK commercializes the drug in ex-U.S. territories under the trade name Volibris.

In the six months ended Jun 30, 2015, Gilead recorded Letairis revenues of $327 million. Approval of Letairis in combination with Adcirca is expected to boost the drug's revenues. However, we note that Letairis' label carries a Boxed Warning and an associated Risk Evaluation and Mitigation Strategy program regarding the risk of embryo-fetal toxicity, which may limit its sales potential.

Gilead carries a Zacks Rank #3 (Hold). Regeneron Pharmaceuticals, Inc. REGN is a favorably ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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