
Top FDA News for Week of Sept. 20, 2021
Pfizer receives an EUA for its COVID-19 booster, a biosimilar of Lucentis to treat macular degeneration is approved, Incyte receives two approvals for JAK inhibitors, one for atopic dermatitis and another for GVHD, and more FDA news.
FDA issues EUA for booster of Pfizer’s COVID-19 vaccine.
The FDA
The FDA authorized the booster to be given at least six months after completion of the primary vaccination.
FDA approves first biosimilar to treat macular degeneration.
The FDA has
Byooviz is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders, which can cause irreversible blindness or visual impairments in adults in the United States.
The FDA approval of Byooviz was based on a totality of evidence including analytical, nonclinical data, and clinical data. In a phase 3 study, the efficacy, safety, pharmacokinetics, and immunogenicity of Byooviz was compared with Lucentis in patients with wet AMD.
FDA approves Jakafi for GVHD.
The FDA has
Graft-versus-host disease is a
This approval is the fourth FDA-approved indication for Jakafi, which received FDA-approval in 2019 for steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
FDA approves topical JAK inhibitor for atopic dermatitis.
The FDA has approved Incyte’s Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of atopic dermatitis such as itch, inflammation, and skin barrier dysfunction.
Opzelura is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib.
FDA approves Tivdak for advanced cervical cancer.
The FDA has granted
The approval is based on the phase 2 innovaTV 204 trial, which evaluated 101 patients.
Tivdak is an ADC composed of Genmab’s human monoclonal antibody directed to tissue factor and Seagen’s ADC technology that uses a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody.
FDA approves Cabometryx for thyroid cancer.
The FDA has
This is more than two months ahead of the Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021. DTC is the most common type of thyroid cancer in the United States, and patients who are resistant to radioactive iodine treatment face a poor prognosis.
FDA accepts BMS application for Opdivo/Relatimab combination for advanced melanoma.
The FDA
The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial, which demonstrated that the combination therapy achieved progression-free survival benefit of 10.1 months compared with 4.6 months for Opdivo alone.
FDA has accepted application for rare epilepsy.
The FDA
The application is supported by data from the Marigold study, a phase 3 trial in 101 patients. Patients treated with ganaxolone showed a 30.7% median reduction in 28-day major motor seizure frequency, compared with a 6.9% reduction for those receiving placebo.
Patients in the open-label extension study treated with ganaxolone for at least 12 months experienced a median 49.6% reduction in major motor seizure frequency.
Ganaxolone received orphan drug designation in
AbbVie submits Skyrisi NDA for Crohn’s disease.
AbbVie has submitted an
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