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FDA Alerts

FDA New Drug Approval Roundup (Jan/Feb 2022)

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Vabysmo for “wet” age-related macular degeneration and diabetic macular edema

The U.S. Food and Drug Administration approved Vabysmo (faricimab-svoa; Roche) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). Approval is based on results from four phase 3 studies that demonstrated non-inferior vision gains in patients treated with Vabysmo given at intervals of up to 4 months compared to patients treated with aflibercept given every 2 months in the first year. (1/28/2022)

Read more here.

Enjaymo for use in patients with cold agglutinin disease

The U.S. Food and Drug Administration approved Enjaymo (sutimlimab-jome; Sanofi) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).

Approval is based on the results from the 26-week open label, single arm pivotal Phase 3 study in 24 patients with CAD and a recent history of blood transfusion, in which Enjaymo met its primary efficacy endpoint of a composite endpoint defined as the proportion of patients who achieved normalization of hemoglobin (Hgb) level ≥12 g/dL or demonstrated an increase from baseline in Hgb level ≥2 g/dL at the treatment assessment time point and no blood transfusion from weeks 5 through 26 or medications prohibited per the protocol from weeks 5 through 26. (2/4/2022)

Read more here.

Pyrukynd for hemolytic anemia in adults with pyruvate kinase deficiency

The U.S. Food and Drug Administration Pyrukynd (mitapivat; Agios Pharmaceuticals) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

Approval is based on results from the ACTIVATE and ACTIVATE-T studies, which were conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively, in which mitapivat demonstrated a statistically significant increase in hemoglobin in patients with PK deficiency who are not regularly transfused. (2/17/2022)

Read more here.

Vonjo for myelofibrosis and thrombocytopenia

The U.S. Food and Drug Administration has approved Vonjo (pacritinib; CTI BioPharma) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

Approval is based on efficacy results from the pivotal Phase 3 PERSIST-2 study in which 29% of cohort of patients with baseline platelet counts below 50 × 109/L who were treated with pacritinib 200 mg twice daily had a reduction in spleen volume ≥35% compared to 3% of patients treated with best available therapy. (2/28/2022)

Read more here.

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