There were quite a few updates on the regulatory front this week with Synergy (SGYP – Free Report) gaining FDA approval for its constipation drug, while both Gilead (GILD – Free Report) and AbbVie (ABBV – Free Report) got accelerated assessment for their HCV drugs in the EU.
Recap of the Week’s Most Important Stories
AbbVie HCV Regimen gets Accelerated Review in the EU: AbbVie’s regulatory application for its experimental, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) has been accepted for review by the European Medicines Agency (EMA) for accelerated assessment. AbbVie is seeking approval for the G/P regimen for use in all major chronic hepatitis C virus (HCV) genotypes. Approval, which could come in the second half of the year, would provide patients with a shorter-duration treatment option. G/P has been submitted for review in the U.S. as well while the company will seek approval in Japan in the first quarter of 2017.
Meanwhile, AbbVie’s cancer drug, Imbruvica, gained approval for a 5th indication – relapsed/refractory marginal zone lymphoma, a rare type of non-Hodgkin’s lymphoma.
Accelerated Assessment in EU for Gilead HCV Regimen: Gilead’s investigational, once-daily, single tablet HCV regimen has been granted accelerated assessment by the EMA. Gilead is looking to get the sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) regimen approved for the treatment of chronic HCV patients. The regimen has been submitted for review in the U.S. as well.
FDA Nod for Synergy Drug: Synergy gained FDA approval for Trulance (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC). The CIC market is large but underserved with about 33 million Americans estimated to be affected by the ailment while approximately 14% of the global population suffers from CIC. Trulance, which is scheduled to be launched later this quarter, represents another treatment option in the CIC market. Synergy is a Zacks Rank #3 (Hold) stock.
Actelion’s Opsumit Fails in Phase III Study: Actelion (ALIOF – Free Report) announced disappointing results from a late-stage study (MAESTRO) on Opsumit for the treatment of patients with pulmonary arterial hypertension (PAH) due to Eisenmenger syndrome. Eisenmenger syndrome is the most advanced form of PAH in conjunction with congenital heart disease (PAH-CHD).
We note that Actelion has significantly outperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the last one year with the company’s shares gaining 66.84% compared to the industry decline of 13.46% during this period. Actelion is currently in exclusive talks with Johnson & Johnson JNJ regarding a potential transaction.
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