Glaxo's Nucala Label Expansion Application Gets FDA Approval

GlaxoSmithKline plc GSK announced that the FDA has approved the label expansion of eosinophilic asthma drug, Nucala, to include treatment of eosinophilic granulomatosis with polyangiitis ("EGPA"). With this approval, Nucala becomes the first targeted treatment for EGPA, which was previously known as Churg-Strauss syndrome.

EGPA is a rare autoimmune disease, which causes inflammation in small and medium-sized blood vessels. It can cause damage to lungs, sinuses, skin, heart, gastrointestinal tract, nerves and other organs.

Nucala is presently approved for treating severe eosinophilic asthma.

Shares of Glaxo have decreased 7.8% so far this year, underperforming the industry’s gain of 17.4% in that period.

Coming back to the news, the FDA approved the label expansion based on data from the phase III study – MIRRA – which evaluated a dose of 300mg of Nucala as an add-on therapy to standard of care in relapsing and/or refractory EGPA versus placebo.

Data showed that Nucala achieved statistically significant improvement in primary endpoints – accrued time in remission and proportion of patients achieving remission – compared to placebo.

According to principal investigator of MIRRA study, Dr. Michael Wechsler, EGPA patients often suffer from recurrent relapses, which may permanently damage tissue and organ. Data from the study has shown that Nucala has increased accrued time in remission and also reduced the frequency of relapse and flares. The patients were also able to reduce their dose of corticosteroid compared to placebo.

Currently, approved treatments for EGPA generally work by reducing active inflammation and by suppressing the body’s immune response.

A supplemental biologics license application for label expansion of Nucala to include treatment of chronic obstructive pulmonary disease is under review in the United States.

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Zacks Rank & Stocks to Consider

Glaxo carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the pharma sector include Celldex Therapeutics, Inc. CLDX, ACADIA Pharmaceuticals Inc. ACAD and Corcept Therapeutics Inc. CORT. All the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celldex’s loss estimates narrowed from $1.03 to 93 cents for 2017 and from 96 cents to 90 cents over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.36%.

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Corcept’s earnings per share estimates have increased from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 14.32%. The company’s stock is up 131.3% so far this year.

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