A slew of FDA approvals landed across dermatology, HIV, and cardiometabolic disease this week, with each approval expanding treatment options for patients who had few or no targeted alternatives.

Priovant wins FDA approval for Lisraya

Priovant Therapeutics announced that FDA has approved Lisraya (brepocitinib) 30 mg for the treatment of adults with dermatomyositis. Lisraya is a pill taken once daily and can be prescribed by healthcare professionals in the U.S. effective immediately.¹

Dermatomyositis is a rare systemic autoimmune disease characterized by progressive muscle weakness and extensive, painful, and pruritic skin lesions that significantly impair patients' quality of life through physical disability, pain from both muscle and skin disease, cutaneous disfigurement, skin sensitivity to light and touch, and high levels of dependency on chronic high-dose steroids.¹ Lisraya, a first-in-class TYK2/JAK1 inhibitor, is the first and only targeted therapy approved for dermatomyositis, providing improvements in skin disease, muscle strength, physical function, and overall disease burden, alongside substantial steroid-sparing benefit.¹

The approval follows the Phase III Valor trial, the largest dermatomyositis trial ever conducted. In Valor, benefits on the primary endpoint, the myositis Total Improvement Score, were seen as early as Week 4, increased over time, and were sustained to the end of the 52-week study.¹ Most patients treated with Lisraya achieved both moderate or better improvement on the Total Improvement Score and minimal or no steroid use by the end of the study (55%, compared with 30% on placebo).

Patients receiving Lisraya reported more than four times as much improvement as those on placebo when asked to rate overall disease activity, and achieved clinically meaningful improvement on a measure of everyday function, including pain and activities such as getting dressed, climbing stairs, and running errands, while placebo patients worsened.1 The most common adverse reactions in Valor were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.¹

"Today's approval of Lisraya marks a historic moment for the dermatomyositis community and reflects years of extraordinary work and sacrifice by the team at Priovant, our partners, and, above all, the investigators and patients who participated in the brepocitinib development program," said Ben Zimmer, chief executive officer of Priovant. "I am thrilled that adults with dermatomyositis finally have a fundamentally new treatment option – one specifically designed to target the biology of their disease and shown to meaningfully improve how patients feel and function in their daily lives."

Gilead wins FDA approval for Bixlenvo

Gilead Sciences, Inc. has announced FDA’s approval of Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only single tablet regimen option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available single tablet regimens.²

The novel treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor with a novel mechanism of action and no cross-resistance to other antiretrovirals.² The approval is based on results from the Phase III Artistry-1 and Artistry-2 trials, with data presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections.²

The trials evaluated Bixlenvo in adults with HIV who are virologically suppressed, including those who switched from complex multi-tablet regimens or from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo was able to demonstrate comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified; the most common adverse reactions reported in at least 2% of participants across the program were headache, nausea, and diarrhea.² Detailed Artistry-1 results were published in The Lancet, and Artistry-2 results were published in Lancet HIV.²

"Bixlenvo offers a new once-daily single tablet regimen designed for the evolving needs of people with HIV," said Chloe Orkin, MD, lead primary investigator for Artistry-1 and clinical professor of infection and inequities at Queen Mary University of London. "The approval is a significant advancement in HIV treatment, especially for individuals unable to benefit from guideline-recommended single tablet regimens due to challenges like pre-existing resistance or tolerability. It expands tailored, simplified dosing to people whose needs were not fully met by existing single tablet therapies."

Lilly secures expanded FDA approval for Mounjaro

FDA has expanded its approval for Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with type 2 diabetes who are at high risk for these events.³

Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes.³

The expanded approval was based on results from Surpass-cvot, the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years.³

In the trial, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack, or stroke.³ The estimated hazard ratio for time to first major adverse cardiovascular event was 0.92 (95.3% CI: 0.83, 1.01) for Mounjaro compared with Trulicity. Safety and tolerability were generally consistent with Mounjaro's established profile; the most commonly reported adverse events in Surpass-cvot were gastrointestinal-related, generally mild-to-moderate in severity, and occurred primarily during the dose-escalation period.³

"Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event," said David A. D'Alessio, M.D., study co-author and director of the division of endocrinology and metabolism at Duke University School of Medicine. "While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked. This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time."

Sources

1. Priovant Announces FDA Approval of Lisraya (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S. Priovant August 27, 2026, https://www.globenewswire.com/news-release/2026/08/27/3352364/0/en/priovant-announces-fda-approval-of-lisraya-brepocitinib-for-adults-with-dermatomyositis-now-available-in-the-u-s.html
2. U.S. FDA Approves Gilead’s Bixlenvo, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens Gilead Sciences August 27, 2026, https://www.gilead.com/news/news-details/2026/u-s--fda-approves-gileads-bixlenvo-a-new-once-daily-single-tablet-option-for-virologically-suppressed-adults-with-hiv-including-those-on-complex-regimens
3. FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes Eli Lilly and Company August 28, 2026, https://www.prnewswire.com/news-releases/fda-approves-lillys-mounjaro-tirzepatide-to-reduce-cardiovascular-risk-in-adults-with-type-2-diabetes-302862415.html