Expanded Approvals for Dupixent, Keytruda, Mavyret, Nucala, Susvimo; New Meds: Widaplik for High Blood Pressure, Yeztugo for HIV prevention

Jun 30, 2025

Dupixent (dupilumab) injection

Eczema drug Dupixent received expanded approval to treat bullous-pemphigoid, a condition with itchy blisters or rash experienced primarily in elderly patients. Earlier this year, Dupixent received expanded approval as an add-on treatment for Chronic Obstructive Pulmonary Disease (COPD) and chronic spontaneous urticaria (chronic hives with no known cause). Dupixent was approved in 2017.
Safety Label Change for Dupixent and Revised Label.

Read or add ratings for Dupixent at Ask a Patient website.

Keytruda (pembrolizumab) injection

Cancer drug Keytruda received expanded approval for advanced head and neck cancer. Its label was updated with clinical trials results that support the approval. Keytruda was approved in 2014.
Safety Label Change for Keytruda

Mavyret (glecaprevir and pibrentasvir) tablets

Mavyret treats adults and children 3 years of age and older with chronic (lasting a long time) hepatitis C virus (HCV). It received expanded approval to treat acute (recently infected) hepatitis C virus (HCV). Mavyret was approved in 2017.
Safety Label Change for Mavyret

Nucala (mepolizumab) injection, for subcutaneous use

Asthma drug Nucala received expanded approval as an add-on maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). It is not approved for treating acute (or sudden onset) symptoms of asthma or COPD. Nucala was approved in 2015.
Safety Label Change for Nucala

Susvimo (ranibizumab injection) ocular implant

Wet AMD (Age Related Macular Degeneration) treatment Susvimo received approval to treat diabetic retinopathy. This is Susvimo’s second diabetes-related approval: in February 2025 it was approved for patients with Diabetic Macular Edema (DME).

Many people with diabetes have early stage diabetic retinopathy, a condition where tiny blood vessels in the eye leak, making the retina swell. This is called non proliferative diabetic retinopathy (NDPR), and may not have any symptoms in early stages. Advanced stage of the disease, PDR (proliferative diabetic retinopathy) happens when the retina starts growing new blood vessels, which can cause scarring and serious vision problems.

Susvimo consists of a tiny implanted device that delivers ranibizumab to the eye continuously. The advantage of this delivery system is that patients can avoid going to the doctor for monthly medication injections. The implant is refilled every six months at the doctor’s office. While convenient, the implant is associated with greater risk of endophthalmitis (eye infections) than monthly injections of ranibizumab.

Clinical trials of the Susvimo for diabetic retinopathy showed that 9.4% of participants experienced eye hemorrhaging (vitreous hemorrhaging) vs. about 5% experiencing the side effect when using Susvimo as treatment for Wet AMD. The active ingredient in Susvimo, ranibizumab, was approved in 2006; the Susvimo product was approved in 2021.

Read more about diabetic retinopathy at American Academy of Ophthalmology.

Susvimo FDA Safety Label Change and Revised Drug Label

New Medication Approvals: Widaplik and Yeztugo

Widaplik (telmisartan, amlodipine, indapamide) tablets

The FDA approved George Medicines’ Widaplik, a triple-combination medication for treating high blood pressure. This med is also approved as an initial treatment for patients who might otherwise need several medications to control their blood pressure. Widaplik combines telmisartan, an angiotensin II receptor blocker, amlodipine, a calcium channel blocker, and indapamide, a thiazide-like diuretic. It has a boxed warning about fetal toxicity. The drug should not be taken while pregnant. Widaplik was approved in June 2025.

FDA Approval Letter and Widaplik Drug Label

Yeztugo (lenacapavir) tablets and injection

The FDA approved Gilead Science’s Yeztugo as a pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults. The treatment regimen, consisting of both an injection and oral tablets, is only needed every six months. Gilead reports that ≥99.9% of clinical trials participants have remained HIV-free. Gilead Science’s Sunlenca product (also containing the active ingredient lenacapavir) was approved as an HIV treatment in 2022. Yeztugo was approved in June 2025.

FDA Approval Letters and Yeztugo Drug Label

Gilead Sciences press release

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