Good news for GSK's Synflorix, FDA review of RLS drug put back

GlaxoSmithKline says that it is received the thumbs-up from the World Health Organisation for Synflorix, the first endorsement for a vaccine against pneumococcal disease.

The WHO has awarded “prequalification for global use” of Synflorix, which helps protect against 10 strains of pneumococcal disease. The agency’s decision means that United Nation agencies can now purchase the vaccine on behalf of developing countries which will accelerate global access to the product.

GSK added that the prequalification covers a one-dose vial presentation of Synflorix and it is working closely with the agency to review a file for a two-dose vial “that could make more efficient use of limited refrigeration space in low-resource settings”. The vaccine was approved in Europe this April for use in children from six weeks to two years of age to provide protection against invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae. It is now approved in over 40 countries, including Canada and Australia.

GSK currently manufactures Synflorix at its plant in Belgium and in June it opened a $411 million facility in Singapore. This will have “the capacity to meet the enormous need for pneumococcal vaccines in global markets in the coming years”, the company added.

FDA delays gabapentin enacarbil PDUFA date
Meantime, GSK and partner XenoPort say that the US Food and Drug Administration has extended the original Prescription Drug User Fee Act date for its review of their restless legs syndrome drug GSK1838262/XP13512 (gabapentin enacarbil) to February 9 next year. The original date for the New Drug Application review was November 9.

GSK submitted a risk evaluation and mitigation strategy for GSK1838262, which was refiled under the proposed brand name Solzira at the beginning of this this year. The FDA has accepted the submission as “a solicited major amendment” and used its option to extend the PDUFA date.

The compound, which is partnered with Astellas in Japan and five Asian countries, is also being developed for restless post-herpetic neuralgia, painful diabetic neuropathyand migraine prophylaxis.