Berdazimer 10.3% gel (Zelsuvmi – Ligand), a first-in-class nitric oxide-releasing agent, has been approved by the FDA for topical treatment of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available in the US for treatment of molluscum contagiosum and the first that can be applied by the patient or caregiver at home; cantharidin 0.7% solution (Ycanth), which is applied by a healthcare professional, was approved earlier for use in patients ≥2 years old.1
MOLLUSCUM CONTAGIOSUM ― A skin infection caused by...
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RELEASE
The FDA has removed the Risk Evaluation and Mitigation Strategy (REMS) requirement for the endothelin receptor antagonists ambrisentan (Letairis, and generics), bosentan (Tracleer, and generics), macitentan (Opsumit, and generics; Opsynvi), and aprocitentan (Tryvio), and the endothelin receptor antagonist and angiotensin II receptor antagonist sparsentan (Filspari) that was initially implemented because of a possible risk of embryofetal toxicity.1
Ambrisentan, bosentan, and macitentan are FDA-approved for treatment of pulmonary arterial hypertension (PAH); aprocitentan is approved for treatment of hypertension and sparsentan is approved to slow kidney function decline in patients with primary immunoglobulin A nephropathy (IgAN).
The embryofetal toxicity REMS requirement for these drugs was based on studies in pregnant animals. Removal of the REMS …