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Glaxo's Eosinophilic Asthma Drug Nucala Wins CHMP Backing

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GlaxoSmithKline plcGSK came up with two important announcements related to its respiratory drugs, Nucala and Relvar/Breo Ellipta.

Nucala a Step Closer to European Approval

Glaxo announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion in favor of approving Nucala (mepolizumab) as an add-on treatment for adults suffering from severe refractory eosinophilic asthma.

Nucala, an experimental anti-interleukin-5 (IL-5) monoclonal antibody, is being developed for subcutaneous administration every four weeks. Upon approval, Nucala would be the first anti IL-5 to be approved for this difficult-to-treat population.

A final decision regarding the candidate's approval status should be out by year end. With the CHMP in favor of approving Nucala, we believe chances of gaining EU approval are high.

We remind investors that Nucala is under review in the U.S. (response expected by Nov 4, 2015) and Japan for the same indication. Further regulatory filings are expected over the remainder of the year and in 2016.

And it's not just Glaxo. Several companies including Teva Pharmaceutical Industries Limited TEVA and AstraZeneca plc AZN are looking to bring their anti IL-5 antibodies to the market for the treatment of severe asthma and chronic obstructive pulmonary disease (COPD).

Relvar Ellipta's Japanese Filing for COPD in 1Q16

In a separate press release, Glaxo and Theravance Inc. THRX announced their intention to submit a supplemental Japanese new drug application (sJNDA) for Relvar/Breo Ellipta (fluticasone furoate/vilanterol) in the first quarter of 2016. The companies intend to seek approval for the treatment of patients with COPD.

Relvar/Breo Ellipta is already approved in Japan for the treatment of asthma in patients aged 15 years and older. In the U.S., the drug is approved for both COPD and asthma.

We note that Glaxo has a collaboration agreement with Theravance for Relvar/Breo Ellipta and Anoro Ellipta (COPD). Relvar/Breo Ellipta generated sales of £94 million in the first half of 2015. Label expansion would boost the drug's sales further.

Glaxo is a Zacks Rank #3 (Hold) stock. Teva is a better-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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