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(Alliance News) - ViiV Healthcare, a company majority-owned by GlaxoSmithKline PLC, on Tuesday said its HIV drug Cabotegravir has been granted a priority review by the US Food & Drug Administration.
The FDA has set a target approval date of January 24 next year for the new drug application.
Pfizer Inc and Shionogi Ltd are minority shareholders in ViiV, a London-based HIV treatment specialist.
Kimberly Smith, head of Research & Development at ViiV said: "The FDA's priority review designation of cabotegravir long-acting for pre-exposure prophylaxis underscores the importance of this medicine. In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options."
In separate news, ViiV announced it has signed an exclusive license agreement with Japanese pharmaceutical firm Shionogi to develop a further HIV treatment with potential for ultra long-acting dosing intervals.
Under the terms of the agreement, ViiV will make an upfront payment of GBP20 million to
Shionogi, a GBP15 million payment for the achievement of a clinical development milestone and royalties on net sales.
The agreement between the two pharmaceutical giants aims to build on the success of long-acting HIV drugs Dolutegravir and Cabotegravir in creating future treatments.
Shares in GlaxoSmithKline were marginally lower at 1,384.00 pence on Tuesday afternoon in London.
By Will Paige; willpaige@alliancenews.com
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