GSK Submits for Subcutaneous Formulation of Benlysta in US, Europe
September 23 2016 - 5:44AM
Dow Jones News
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 razak.baba@wsj.com; Twitter:
@Raztweet
(END) Dow Jones Newswires
September 23, 2016 05:29 ET (09:29 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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