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Glaxo’s Subcutaneous Formulation of Benlysta Approved in EU

Zacks

GlaxoSmithKline plc GSK announced approval in EU for a new self-injectable subcutaneous ("SC") formulation of Benlysta for systemic lupus erythematosus ("SLE"). The subcutaneous formulation is already approved in the United States.

Benlysta is presently available in an intravenous formulation as an add-on therapy for SLE.

The SC formulation has been approved as a once-weekly injection (200 mg dose) available through single-dose prefilled syringe or a single-dose prefilled pen, which will enable patients to self-administer.

Shares of Glaxo are down 8.9% so far this year, underperforming the industry’s gain of 14.4% in that period.


Coming back to the news, the approval was based on data from the phase III BLISS-SC study, which showed that Benlysta in combination with standard of care (SoC) led to significant reduction in disease activity compared to placebo plus SoC.

The approval for the SC formulation of Benlysta in the United States, EU and Japan this year will offer additional administration options to patients as well as physicians.

SLE is a chronic, incurable, autoimmune disease, which occurs in almost 70% of the estimated 5 million lupus patients globally. The intravenous formulation is approved in more than 70 countries. Glaxo is looking to get the SC formulation approved in many of them.

Benlysta registered sales of approximately $327 million in the first nine months of 2017, up 18% year over year. The impact of approval for SC formulation remains to be seen.

Zacks Rank & Stocks to Consider

Glaxo carries a Zacks Rank #3 (Hold).

Better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. SCMP, Corcept Therapeutics Incorporated CORT and Achillion Pharmaceuticals, Inc. ACHN. While Sucampo sports a Zacks Rank #1 (Strong Buy), Corcept and Achillion carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucampo’s earnings per share estimates have increased from $1.01 to $1.11 for 2017 and from $1.06 to $1.21 for 2018 over the last 30 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 15.63%.

Corcept’s earnings per share estimates have moved up from 45 cents to 48 cents for 2017 and from 77 cents to 80 cents for 2018 over the last 60 days. The company delivered positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has rallied 144.5% year to date.

Achillion’s loss estimates per share have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2017 over the last 30 days. The company came up with positive earnings surprise in two of the trailing four quarters with an average beat of 4.51%.

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