GSK Submits for Subcutaneous Formulation of Benlysta in US, Europe

By Razak Musah Baba

LONDON--GlaxoSmithKline PLC (GSK.LN) said Friday that it has filed regulatory submissions in the U.S. and Europe, seeking approval for the drug Benlysta as a subcutaneous formulation type of injection for patients with systemic lupus disease.

Subcutaneous formulation is a form of injection whereby the drug is administered under the skin.

The pharmaceutical company said regulatory filings in other countries are planned during the course of 2016 and 2017. The subcutaneous formulation of Benlysta is currently not approved for use anywhere in the world.

Benlysta is indicated in the U.S. for the treatment of adult patients with active, autoantibody‑positive, systemic lupus erythematosus who are receiving standard therapy. It is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive, with a high degree of disease activity, the company said.

At 0905 GMT, shares were up 3 pence, or 0.2%, at GBP16.52, valuing the company at GBP80.52 billion ($104.56 billion).

-Write to Razak Musah Baba at [e-mail]; Twitter: @Raztweet

(END) Dow Jones Newswires

September 23, 2016 05:29 ET (09:29 GMT)

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