Labeling updates and warnings through November 2008 for efalizumab (Raptiva)
A boxed warning has been added to the labeling information for efalizumab (Raptiva, Genentech), which is approved for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. This warning highlights the risk of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), occurring in patients treated with efalizumab. Infections that have been observed in efalizumab-treated patients include bacterial sepsis, viral meningitis, invasive fungal disease, PML, and other opportunistic infections.
FDA Approves Combination Therapy for Pulmonary Arterial Hypertension
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with PAH.