GSK's ViiV seeks marketing license for baby-friendly HIV pill

[December 13, 2019]  LONDON (Reuters) - British drugmaker GSK applied on Friday for a license to market its HIV drug dolutegravir in a formulation designed to be easier for babies and children who are living with the virus to swallow.

About 1.7 million children have HIV, most of them in sub-Saharan Africa, the United Nations agency UNAIDS says.

If approved by regulators, the medicine will be the first new generation HIV medicine available in baby-friendly form.

Doctors wanting to use dolutegravir in children with HIV have had no licensed child formulations, meaning they often must prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects.

"Children in today's world, still have fewer options in terms of HIV therapies compared to adults," said Harmony Garges, chief medical officer for ViiV Healthcare, GSK's HIV drugs division.

"We're hopeful this submission will enable approval of dolutegravir across the pediatric spectrum and allow them to have access to the preferred treatment option," she told Reuters.

Doluetragravir is a so-called integrase inhibitor and was originally developed by ViiV, in which Pfizer Inc and Shionogi & Co have small stakes. For the adult formulation, ViiV has already agreed licensing deals with generic companies to sell low-cost versions in poor countries.

New HIV infections among children have fallen by 41% since 2010, but there were 160,000 new cases in babies and children in 2018, and 100,000 children died of AIDS last year, partly due to lack of access to HIV medicines.

Helen McDowell, ViiV's head of government affairs and global public health, said that subject to licenses being granted by U.S. and European drug regulators, the company was planning for an initial roll-out in sub-Saharn Africa next year.

ViiV's version of the child formulation will be priced at "cost of production" she said but declined to give more detail.

ViiV is planning licensing agreements with two generic drugmakers, Mylan Laboratories and Macleods Pharmaceuticals, who aim to make cheaper generic versions of the dispersible pill available within months of ViiV's coming to market, she added.

Indian generic drugmaker Cipla said last month it was seeking regulatory approval for a four-in-one HIV drug combination called Quadimmune, which it promised to price at below $1 a day.

(Reporting by Kate Kelland, editing by Angus MacSwan)

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