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GlaxoSmithKline's Nucala Positive in Label Expansion Study

Zacks Equity Research

GlaxoSmithKline plc.  GSK announced that a phase IIIb study evaluating its respiratory drug Nucala (mepolizumab) met all its primary and secondary endpoints.  

The  MUSCA study showed that patients with severe asthma driven by eosinophilic inflammation when treated with the Nucala added-on to standard of care achieved clinically and statistically significant improvements in their health-related quality of life and lung function when compared with patients treated with placebo and standard of care.

GlaxoSmithKline’s share price has increased 8.5% year to date, while the Zacks classified Large Cap Pharmaceuticals industry gained 7.6%.

Coming back to the press release, the MUSCA study involved 551 patients treated with Nucala 100mg subcutaneous injection, every 4 weeks for a 24 week period.

The results were based on St. Georges Respiratory Questionnaire (SGRQ) score, which is a patient-reported outcome measure used to understand how severe asthma affects a patient's quality of life. The SQRQ scores showed that Nucala improved quality of life by 7.7 units compared to baseline versus placebo after 24 weeks. The result was also nearly double the defined clinically meaningful difference of ≥4.0 units.

The study also met exploratory endpoints where the annual rate of exacerbations (asthma attacks)was reduced by 58%, and the number of exacerbations requiring emergency room visits or hospitalisation was reduced by 68% for people treated with Nucala compared with placebo.

In the US, Nucala is presently approved as an add-on maintenance treatment for patients with severe asthma and with an eosinophilic phenotype. However, Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

The positive data from the MUSCA study highlight the importance of Nucala as a treatment option for patients with severe asthma with an eosinophilic phenotype. Nucala can prove to be of an effective treatment option as it demonstrated improvements in markers of asthma control including quality of life and lung function, thus treating most severe asthma patients.

Zacks Rank & Key Picks

GlaxoSmithKline currently carries a Zacks Rank #2 (Buy). Some other favorably ranked stocks in the health care sector include Heska Corp. HSKA, Sunesis Pharmaceuticals SNSS and Celgene Corp. CELG. While Heska carries a Zacks Rank#1 (Strong Buy), Sunesis Sciences and Celgene carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all four trailing quarters with an average beat of 291.54%.

Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.

Celgene’s earnings estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 5.08%.

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