Novartis (NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rendered a positive opinion to Signifor long acting release (LAR) formulation to treat adults with acromegaly for whom surgery is not an option or has not been curative. These patients were inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).
We also note that Novartis is seeking label expansion for Signifor for the treatment of acromegaly. Signifor is approved in the U.S. and EU for the treatment of adults with Cushing's disease.
The CHMP recommendation was based on positive results from two multicenter phase III studies, C2402 and C2305. Data from both the studies showed that Signifor LAR formulation had superior efficacy in providing biochemical control, as measured by both GH and IGF-1 levels, compared to a first generation SSA. However, even though the incidence and severity of adverse events was similar to other SSAs, there was a higher frequency and degree of hyperglycemia-related adverse events with Signifor LAR formulation.
We note that the European Commission generally follows the recommendations of the CHMP but is not bound by it.
In addition, Novartis announced positive results from two phase III studies (FUTURE 1 and FUTURE 2) on pipeline candidate secukinumab (AIN457).
Novartis is evaluating secukinumab for the treatment of psoriatic arthritis (PsA). The studies evaluated the efficacy of secukinumab in PsA compared to placebo and to assess its safety and tolerability. Both the trials met primary and key secondary endpoints. Results of the trial showed that treatment with secukinumab improved signs and symptoms of PsA along with improving peripheral joint disease and preventing joint damage as compared to placebo.
Novartis expects to submit data from the trials for regulatory filings in 2015. We note that Novartis had submitted secukinumab to regulatory bodies in both the U.S. and EU in 2013 for the treatment of psoriasis. Novartis is also evaluating secukinumab for the treatment of ankylosing spondylitis (AS) and rheumatoid arthritis (RA).
The successful development and commercialization of secukinumab for the treatment of psoriasis will further strengthen Novartis’ dermatology portfolio. Novartis already has Xolair in its dermatology portfolio which is approved for the treatment of refractory chronic spontaneous urticaria (CSU) in the EU and is known as refractory chronic idiopathic urticaria (CIU) in the U.S.
We are encouraged by the positive bout of news regarding Novartis. The successful development and commercialization of the pipeline is important for Novartis as it faces generic competition for several key drugs such as Gleevec, Zometa and Diovan.
Novartis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader health care sector include Johnson & Johnson (JNJ), Shire (SHPG) and Bristol-Myers Squibb (BMY). All three carry a Zacks Rank #2 (Buy).
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