Gilead’s Truvada gets expanded indication
The Food and Drug Administration has approved an expanded indication for Gilead Sciences’ Truvada. The combination of emtricitabine and tenofovir disoproxil fumarate is now approved to reduce the risk of HIV transmission in adolescents weighing at least 35 kg in combination with safer sex practices.
The expanded indication is in addition to Truvada’s previous indication as pre-exposure prophylaxis, or PrEP, in adults that was granted in 2012. Gilead said it sought expanded indication for the drug based on a study from the Centers for Disease Control and Prevention that found young adults between 13 and 24 years old comprised 21% of new infections in 2016, with young men who have sex with men making up 81% of new cases.
“By expanding the number of at-risk individuals who can consider Truvada as a prevention option, we have taken another important step toward helping to reduce HIV transmission rates and improve public health in the United States,” said Andrew Cheng, chief medical officer at Gilead Sciences. “Gilead is committed to addressing unmet needs in HIV prevention and treatment and we look forward to continuing that work with our research and advocacy partners.”
The expanded indication was based on a clinical trial by the Adolescent Medicine Trials Network for HIV/AIDS, in which young men who have sex with men ages 15 to 17 years old received Truvada once daily for PrEP. The drug demonstrated a similar safety profile in participants as in adults in Truvada trials the company said.
The company noted that Truvada is not meant to replace such prevention tools as condoms and that patients who receive the drug should be counseled to strictly adhere to the daily dosing schedule. Additionally, patients should receive HIV screening to confirm a negative status immediately before starting treatment, and every three months while being treated with Truvada.
“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose, policy and advocacy manager at HIV/AIDS advocacy organization NMAC. “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it, particularly among communities disproportionately impacted by the disease, including young Black and Latino men in the United States.”
FDA approves Pfizer’s epoetin alfa biosimilar Retacrit
The Food and Drug Administration on Tuesday approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa).
The biosimilar, from Pfizer’s Hospira was approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
“It is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” stated Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”
Pfizer said that it would be working with Vifor Pharma on commercialization in certain channels for Retacrit — the company’s third approved biosimilar in the United States. The lower-cost alternatives to branded biologic drugs — which are not interchangeable products — are set to play a big role in the Trump Administration’s plan to lower drug prices.
“As the first approved epoetin alfa biosimilar in the United States, Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients,” said Berk Gurdogan, U.S. institutions president at Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”
Aquestive Therapeutics settles patent infringement case with Par Pharmaceuticals
WARREN, N.J. — Specialty pharmaceutical company Aquestive Therapeutics has reached a settlement agreement resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film.
Indivior, a marketer and distributor of Suboxone, joined Aquestive in the settlement with Par Pharmaceuticals, an operating company of Endo International and IntelGenx Technologies Corp.
Under the settlement agreement, Par Pharmaceuticals and IntelGenx agreed to launch their proposed generic version of the buprenorphine and naloxone sublingual film no earlier than Jan. 1, 2023. The patent-infringement litigation has been pending in the U.S. District Court for the District of Delaware. As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
“This settlement once again demonstrates the value our intellectual property and know-how represent for us and our partners,” stated Keith Kendall, CEO of Aquestive. “We will continue to focus our PharmFilm technology platform on innovating within difficult disease states such as epilepsy, Parkinson’s and ALS.”