By Dina Bisley and Julie SteinHusen
Los Angeles: Giliad Science Lenakpavir was approved by the US Food and Drug Administration on Wednesday, a twice a year -old injection, to prevent HIV transition in adults and adolescents at risk of a fatal virus contract.
Investors and activists of AIDS were eagerly awaiting a regulatory decision for the drug that could be sufficiently favorable to help end the 44 -year -old HIV epidemic.
It is the US In one year under a brand called Yeztugo, 28,218 will be sold at a list of.
Lenakpvir, a part of a class of drugs called capsid inhibitors, proved almost 100% effective in preventing HIV in large tests last year, increasing the new hope of disrupting the transition of the virus that infects 1.3 million people a year.
Kevin Robert Frost, CEO of the Foundation for AIDS Research, said in a statement that “Yeztugo” would be as effective as accessible and affordable, “said Giliad and the US government to ensure that Lenakapavir could get it. “
Gilid said he was working to protect the health insurer’s coverage. It states that it will provide co-pay assistance for people who insure insurers, and may be free of charge for some under their program for insurance companies.
HIV prevention drugs, known as pre-exposure prophylaxis or prep, are widely available. But there are most daily tablets, including normal versions of Gilid’s older drug truvada, which requires strict adherence to effective. Gilid said that Yeztugo costs other branded drugs.
“This is a landmark moment,” Gilead’s chief executive Daniel O’Day said approval.
“We believe that Lenakpavir is the most important tool that we have to bend the arc of the epidemic and that the epidemic is yet to be moved to history books.”
Director of the UCLA Center for Clinical AIDS Research and Education. Rafael Landovitz said in an email that the availability of twice the annual HIV prevention tool is a “huge advance”. But he said that the high projection value of the product “will almost certainly complicate the paying coverage and accesses cess.”
Gilead’s United States plans to have a wide roleout of the drug in collaboration with rapid projections as well as global partners.
Gilead’s Chief Commercial Officer, Johnna Mercyier, said that the company’s “final game” is to normalize the pre -use, including the most prevalent virus, including the low -income African countries, where the virus is most prevalent.
City Research analyst Off F. Mitchham said they expect Yeztugo’s inauguration will be slow and stable, with annual sales reaching $ 2.8 billion by 2030.
Mercier said they expect about 75% of insurance companies, including government health schemes, will cover Lenakpavir for PAP within about six months, the number would be 90% within 12 months of launch.
This drug is currently in the U.S. The Sunlenka is sold as a treatment under the brand that has become resistant to other drugs for patients with advanced disease.
Paper cut
In December, the President’s Emergency Plan for AIDS Relief (PEPFAR) signed an agreement to fight AIDS, tuberculosis and malaria with global funds under the then President B Biden, if it is to prevent the US for prevention. To provide treatment for 2 million people for three years if wins regulatory approval.
It will allow unprecedented early admission to sophisticated treatment, as six common drugmakers licensing production from gilied gear for the production of low-cost versions in 120 Resource-Limited countries.
AIDS activists have seen the drug as a way of significantly slowing the epidemic, but the Trump administration cuts the paper in the U.S. A concern about the commitment to the government’s rollout.
O Day admitted that the changes were “challenging”, but said that the company has continued the debate with both Global Fund and Paper.
“I believe that there will be a source of funds for this, and these organizations will prefer this kind of prevention.”
(Reported by Julie Steinhussen in Dina Bisl in Los Angeles and Chicago; Bill Berkrot and Leslie Edler edit)
