The License agreement between the Medicines Patent Pool (MPP) and ViiV Healthcare over a drug Dolutegravir (DTG) has brought new hope in the field of medicine. This New Drug Application (NDA) follows the approval of dolutegravir by the US Food and Drug Administration (FDA) in August 2013 under the brand name Tivicay®, approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs).
The agreements would allow generic manufacturers to produce low-cost versions of DTG for countries with the highest HIV burden, where 93% of adults and 99% of children living with HIV in the developing world reside. Greg Perry, Executive Director, Medicines Patent Pool stated “Dolutegravir is an innovative HIV therapy, and we will be working closely with generic manufacturers over the next few years to make it available to those most in need as quickly as possible.”
The agreements build on MPP-ViiV’s current partnership, announced in February 2013, which included a broad collaboration on paediatric ARVs and a licence for abacavir (ABC), a key WHO-recommended antiretroviral for children. ViiV is granting the MPP two licences for DTG, one for the production of the medicine for adults and the other for paediatrics. Both licences allow generic manufacturers based anywhere in the world the right to combine DTG with other drugs, including ABC, and develop fixed-dose combinations (FDCs), two or more active drugs in a single dosage form.
By Akshatha Karthik