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ViiV wins European approval for Tivicay

HIV treatment licensed in combination with other anti-retroviral drugs

ViiV HealthcareViiV Healthcare's potential blockbuster HIV treatment Tivicay (dolutegravir) has been approved by the European Commission.

The first European product approval for ViiV, the decision sees Tivicay licensed for use in combination with other anti-retroviral drugs to treat adults and children over the age of 12 with HIV.

ViiV was formed as an HIV-focused joint venture between GlaxoSmithKline and Pfizer in 2009 and welcomed Shionogi - the originator of dolutegravir - as a partner in 2012.

ViiV chief executive Dr Dominique Limet said: "[This] approval of Tivicay is an important advance, opening the door to new treatment combinations for people living with HIV in Europe.

“Tivicay's clinical development programme was only possible through partnerships with the people living with HIV and healthcare professionals who participated in it, and we aim to move forward together with them based on an absolute commitment to the HIV/AIDS global response.”

The approval was based on safety and efficacy data for the drug from four phase III trials involving both treatment-naïve and treatment-experienced HIV patients.

An integrase inhibitor, Tivicay works by blocking replication of the virus by preventing its DNA from integrating into the genetic material of human immune cells.

The recommended dose of Tivicay for most patients is one 50mg tablet once a day, but for patients with documented or clinically suspected resistance to integrase inhibitors, or when Tivicay is co-administered with certain medicines, its recommended dose rises to twice daily.

Datamonitor has forecast Tivicay, which was approved in the US in August, will become the leading HIV treatment by 2016 and reach annual sales in excess of $2.1bn by 2022.

The company's analysts predict Tivicay will have a “huge impact on the market following EU approval”, thanks to an attractive resistance profile and its lack of need for co-dosing with a boosting agent.

Meanwhile, ViiV said that the first European launches of Tivicay would come “in the immediate future”, but added that the rest would depend on the timing of different countries' pricing and reimbursement processes.

Article by
Dominic Tyer

23rd January 2014

From: Sales

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