Source:\u00a0<\/p>\n
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.<\/p>\n
About 1.7 million children have HIV, most of them in sub-Saharan Africa, the United Nations agency UNAIDS says.<\/p>\n
If approved by regulators, the medicine will be the first new generation HIV medicine available in baby-friendly form.<\/p>\n
Doctors wanting to use dolutegravir in children with HIV have had no licensed child formulations, meaning they often have to prescribe older HIV medicines that can be less potent, harder for children to take, and have more side effects.<\/p>\n
\u201cChildren in today\u2019s world, still have fewer options in terms of HIV therapies compared to adults,\u201d said Harmony Garges, chief medical officer for ViiV Healthcare, GSK\u2019s HIV drugs division. She said she hoped the license application would \u201cenable approval of dolutegravir across the pediatric spectrum\u201d.<\/p>\n
ViiV\u2019s CEO Deborah Waterhouse added in a statement: \u201cFor parents living in resource-poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death.\u201d<\/p>\n
Dolutegravir 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.<\/p>\n
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.<\/p>\n
Helen McDowell, ViiV\u2019s 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-Saharan Africa next year.<\/p>\n
ViiV\u2019s version of the child formulation will be priced at \u201ccost of production\u201d she said but declined to give more detail.<\/p>\n
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\u2019s coming to market, she added.<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":3440,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[2557,692,566,2558,1806],"class_list":["post-3439","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-aids-hiv","tag-gsk","tag-healthcare","tag-hiv-infections","tag-hiv-pill","tag-london"],"yoast_head":"\n