FDA Approves ViiV Healthcare’s Long-Acting Injectable for HIV

December 23, 2021 - FDA recently approved ViiV Healthcare’s long-acting injectable pre-exposure prophylaxis (PrEP) treatment, Apretude, to reduce the risk of sexually acquired HIV-1.

The agency approved Apretude for adults and adolescents weighing at least 77 pounds who are at risk of sexually acquiring HIV and have a negative HIV-1 test prior to initiation. Researchers studied the treatment in both men and women.

Healthcare providers can now administer 600 milligrams of Apretude as few as six times per year.

“The approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, said in the announcement.

“This injection will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” Birnkrant continued.

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FDA based its approval on results from two international Phase 2b/ 3 clinical trials, HPTN 083 and HPTN 084. Both trials evaluated the safety and efficacy of Apretude in over 7,700 participants across 13 countries combined.

Participants who took Apretude started the trial with cabotegravir 30 milligrams and a placebo daily for up to five weeks, followed by Apretude 600 milligram injection at months one and two.

Patients who received Apretude saw a 69 percent lower incidence of HIV compared to tenofovir/emtricitabine (TDF/FTC) tablets in HPTN 083 and a 90 percent lower incidence of HIV compared to TDF/FTC tablets in HPTN 084.

About 38 million people currently live with HIV globally, with 1.7 million new cases reported annually. PrEP is an effective tool to reduce new cases of HIV, helping efforts to end the HIV epidemic.

Gabriel Maldonado, MBA, executive director and CEO of TruEvolution, explained that many people vulnerable to HIV have complex lives that make it hard to take a daily pill. Therefore, many communities need additional HIV prevention options.

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The approval of Apretude is a new option to help these individuals reduce their risk of acquiring HIV.

FDA Approves Treatment For Generalized Myasthenia Gravis in Adults

FDA recently approved Vyvgart (efgartigimod) to treat generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody.

Myasthenia gravis a chronic neuromuscular disease that weakens the skeletal muscle and produces AChR antibodies that interfere with communication between nerves and muscles. Severe weakness attacks can cause breathing problems and become life-threatening.

Vyvgart is an antibody fragment that binds to the neonatal Fc receptor (FcRn), which stops FcRn from recycling immunoglobulin (IgG) back into the blood.

The medication reduces overall IgG levels, including abnormal AChR.

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“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the announcement.

“The approval is an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases,” Dunn continued.

FDA based its approval on a 26-week clinical study of 167 myasthenia gravis patients who were randomized to receive Vyvgart or placebo.

The study showed that more patients with myasthenia gravis responded to Vyvgart during the first cycle (68%) than those who received a placebo (30%). More patients who received the treatment also showed a response on a measure of muscle weakness than those receiving a placebo.

FDA Approves AstraZeneca’s Asthma Treatment

FDA recently approved AstraZeneca and Amgen’s Tezspire for the add-on maintenance treatment of adult and pediatric patients with severe asthma.

The first-in-class biologic targets thymic stromal lymphopoietin (TSLP), an epithelial cytokine.

Tezspire is the first and only biologic to consistently reduce asthma exacerbations across Phase 2 and 3 clinical trials.

“Today’s positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in the announcement.

“With the approval of Tezspire, physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients,” Pangalos continued.

FDA approved Tezspire following a priority review and based on the PATHFINDER clinical trial results. Compared to placebo, the trial found that Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma.

Tezspire is currently under regulatory review in the EU, Japan, and several other countries globally.