GSK’s Arixtra set for expanded licence
pharmafile | July 26, 2010 | News story | Sales and Marketing | Arixtra, Avandia, GlaxoSmithKline, rotarix
GlaxoSmithKline is set to receive a green light to use its anti-clotting drug Arixtra to prevent spontaneous superficial-vein thrombosis (SVT).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Arixtra’s licence be extended to include the treatment of adults with acute symptomatic SVT in the lower limbs who do not have deep-vein thrombosis (DVT).
The Committee’s recommendations are usually passed by European regulators within three months, and if this process is followed it would make Arixtra the first treatment licensed in Europe for SVT.
It would also add to the half-dozen indications Arixtra (fondaparinux) already has in the EU: others include the prevention of venous thromboembolic events (VTE) and initial treatment of acute DVT.
The proposed new indication is for Arixtra 1.5mg/0.3ml and 2.5mg/0.5ml, and GSK’s application was based on results from the CALISTO study, which the company says is the first in SVT to show a clinical effect with an anticoagulant versus placebo.
The EMA also started a review this month into GSK’s diabetes drug Avandia (rosiglitazone), which it expects to finish in September. The brand, approved in combination with metformin (as Avandamet) and glimepiride (Avaglim), is contra-indicated in patients with various heart problems.
The CHMP discussed it last week with patients as well as experts in diabetes, cardiovascular diseases and pharmacovigilance, and says prescribers in Europe must strictly follow recommendations in the product information while its review continues.
GSK already faces legal action over claims the drug raises the risk of heart attacks – and the US Senate Finance Committee claims internal emails show GSK attempted to downplay scientific findings about its safety.
The CHMP is looking at new data on the risk of cardiovascular problems in patients and says it will assess this along with all the other information it has on benefits and risks.
Meanwhile the CHMP has concluded that GSK’s oral vaccine Rotarix continues to have a positive benefit-risk balance, even though a “very small amount” of porcine circovirus 1 (PCV1) DNA has been discovered in it.
Adam Hill
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