GSK seeks licence extensions
pharmafile | August 8, 2013 | News story | Sales and Marketing | Cervarix, EMA, GSK, Votrient
GlaxoSmithKline is seeking to extend the licences of two of its brands, Cervarix and Votrient, in a bid to extend their commercial reach in the European Union.
The manufacturer has submitted regulatory applications for both drugs to the EMA.
Cervarix is currently used to treat Human Papillomavirus (HPV) and is given in three doses to girls aged 9 to 14 years: GSK now wants the dosing schedule to be cut to two.
Instead of vaccinating at months 0, 1 and 6, GSK suggests that it could be done at 0 and 6 months for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions, and cervical cancer related to some HPV types.
The two-dose schedule, which is investigational and not approved anywhere in the world, is not intended as a replacement to the three-dose regime, GSK insists.
The firm received a blow when the UK government favoured Sanofi and MSD’s Gardasil over Cervarix for its HPV vaccination programme.
Around 70% of cervical cancers are caused by HPV and both vaccines focus on stopping this virus and in turn, lowering the risk of cervical cancer.
But Gardasil gives a wider range of protection, preventing infection from four HPV strains as well as anogenital warts, whereas Cervarix only protects against two types of HPV strains and not against any form of genital warts.
In its second submission to the European regulator GSK wants its oncology brand Votrient to add advanced ovarian cancer to its licence, and says it is working on submission plans for other countries.
Votrient gained its most recent European licence last year for patients with advanced soft tissue sarcoma (STS), who have received prior chemotherapy or have progressed within 12 months after adjuvant therapy.
GSK wants to add the maintenance treatment of women with Stage II-IV ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first line chemotherapy. The drug is also indicated to treat renal cell carcinoma.
“This EU filing, the third for pazopanib in less than five years, confirms GSK’s commitment to deliver our oncology pipeline,” said Rafael Amado, GSK’s head of oncology R&D.
Adam Hill
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