Tentative FDA Approval for Oral Pediatric HIV Treatment


Mylan Inc. recently announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR), which is a U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world, means the formulations meet all of the agency’s quality, safety and efficacy standards. Mylan’s products are expected to be eligible for purchase in early 2015.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource-limited countries including all low-middle  income, least-developed countries and sub-Saharan Africa.

In July 2002, former U.S. President Bill Clinton addressed the International AIDS Society in Barcelona. In this  address, President Clinton set the agenda for his foundation’s efforts with respect to fighting HIV/AIDS, saying:

“We cannot lose the war on AIDS and win our battles to reduce poverty, promote stability, advance democracy and increase peace and prosperity.”

In October 2002, CHAI was created to bring care and treatment to people living with HIV/AIDS.

Abacavir was first patented by the Wellcome Foundation, now GlaxoSmithKline. Patents in the U.S. for abacavir expired in 2012, with patents on abacavir expiring throughout the rest of the world in June 2014. Patents protecting lamivudine have also now expired.  See Drugs in Focus – Abacavir. In 2009, GlaxoSmithKline created ViiV Healthcare in partnership with Pfizer, with both companies transferring all their HIV assets, including Abacavir, to the new venture.

The fixed-dose combination of abacavir and lamivudine tablets for oral suspension 60 mg/30 mg and 120 mg/60 mg is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents for pediatric patients. This is the first version of abacavir/lamivudine with scoring to allow for dose adjustment and is also flavored.

David Ripin, Executive Vice President and Chief Scientific Officer for CHAI said, “We are pleased that our partnership with ViiV and Mylan has resulted in an important new pediatric formulation, moving from concept to FDA tentative approval in less than two years.  The new, flavoured dispersible medication will help meet the needs of over 500,000 children being treated for HIV in low middle income countries and demonstrates leadership and innovation on the part of both originators and generic suppliers together to address the needs of paediatric patients worldwide.  We are pleased to have participated in this innovative public-private partnership with the support of the UK Department for International Development.”

“The approval of abacavir and lamivudine tablets for oral suspension for marketing in developing markets demonstrates our commitment to providing the world’s 7 billion people with access to medicine and our continued leadership in enhancing access to ARVs to patients in developing countries,” Mylan CEO Heather Bresch said. “This new, flavored, pediatric formulation is designed to help parents and caregivers give accurate doses of the medication depending on the weight of the child.”

Tags: , , , , , ,

Leave a Reply

You share in the PLI Practice Center community, so we just ask that you keep things civil. Leave out the personal attacks. Do not use profanity, ethnic or racial slurs, or take shots at anyone's sexual orientation or religion. If you can't be nice, we reserve the right to remove your material and ban users who violate our Terms of Service.

You must be logged in to post a comment.