At last, GlaxoSmithKline and partner Ligand Pharmaceuticals have been given the green light from US regulators for clotting disorder treatment Promacta.

Promacta (eltrombopag) has been granted accelerated approval by the US Food and Drug Administration for the treatment of patients with chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The approval of eltrombopag was expected after the agency’s Oncology Drugs Advisory Committee voted 16-0 at the end of May in favour of the drug, which was supported by “the largest database of randomised clinical trial information on investigational therapies for chronic ITP patients”, GSK noted.

However the road to approval has sometimes been a bumpy one. The FDA had orginially set September 19 as the action date for Promacta and agency staffers had aired their concerns about long-term risks with the drug, an oral, non-peptide thrombopoietin receptor agonist, such as liver toxicity, bleeding following drug discontinuation and potential marrow fibrosis.

To counter any fears, GSK is launching Promacta Cares, a programme that prescribers and pharmacies must enroll in before they can prescribe or dispense eltrombopag. The drug will be available next wee and the UK-based drugs major added that it plans to submit a marketing application by the end of the year for the drug in Europe, where it will be sold as Revolade.

Meantime, GSK has been boosted by the news that the Netherlands Vaccine Institute has chosen the drugmaker's cervical cancer jab Cervarix, ahead of Merck & Co’s rival Gardasil, to be used in the country's national immunisation programme.

The programme, which aims to vaccinate girls aged 12-13, will begin in September 2009 and more than 350 000 girls to be vaccinated in the first year. Eddie Gray, president of Pharmaceuticals Europe for GSK, said the firm is delighted by the fact that since Cervarix received approval, “it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe.”