European regulators have made their latest recommendations for drug approvals, with the most eye-catching thumbs-up going to GlaxoSmithKline’s pre-pandemic flu vaccine to treat H5N1.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a marketing authorisation for GSK’s Prepandrix, the first pre-pandemic influenza vaccine. Previously there has been no EU-approved jab against the strain, commonly known as bird flu, with antiretrovirals being the most frequently used treatment.
Jean Stephenne, president of GSK Biologicals, the firm’s vaccine division, said the recommendation “reflects the growing recognition of pre-pandemic vaccination as an important strategy for addressing the current pandemic threat posed by H5N1”. He added that “a number of national governments have expressed significant interest in stockpiling our candidate…to help insure against the devastating impact of a pandemic”.
Positive opinion on Volibris
In addition, GSK also received a positive opinion from the CHMP for its pulmonary arterial hypertension treatment Volibris (ambrisentan), adding that full approval from the European Commission is expected by the end of April 2008. The drug, a non-sulphonamide class endothelin receptor antagonist, is the first PAH medicine indicated for patients classed as World Health Organisation (WHO) Functional Class II and III in Europe.
Eddie Gray, president of GSK’s Pharmaceuticals Europe division, said the positive opinion for Volibris demonstrates the firm’s “continued commitment to the development of medicines for the treatment of PAH”. GSK also markets Flolan (epoprostenol) which is indicated for more severe PAH patients.
Thumbs-up for Adenuric, Mycamine
The CHMP also adopted a positive opinion for Ipsen’s Adenuric (febuxostat), for the treatment of gout, which the French drugmaker said could be the first therapy to treat the disease to be approved since 1964. Also recommended for approval was Astellas’ antifungal agent Mycamine (micafungin).
