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2023 | FDA Drug Approvals | US Pharma News | iPharmaCenter

Regeneron Pharmaceuticals and Sanofi announced that Kevzara (sarilumab) is approved by the US Food and Drug Administration for polymyalgia rheumatica (PMR). It is indicated for patients with an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

The approval was based on the SAPHYR Phase 3 randomized. Patients were randomized to either Kevzara 200 mg every two weeks or a placebo. After 52 weeks, Kevzara met the primary endpoint; 28% of patients on Kevzara achieved sustained remission versus 10% of patients on placebo.

Kevzara was approved under Priority Review by the US Food and Drug Administration. Kevzara was previously approved for moderately to severely active rheumatoid arthritis.


Gilead announced that the US Food and Drug Administration approved Trodelvy (sacituzumab govitecan) for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients who were previously treated with endocrine therapy and two additional systemic therapies.

The approval was based on Phase 3 TROPiCS-02, in which Gilead demonstrated significant progression-free survival and overall survival. Trodelvy demonstrated a median overall survival of 14.4 months versus 11.2 months in patients on chemotherapy. The median progression-free survival was 5.5 months versus 4.0 months, showing an improvement of 34% reduction in disease progression or death.

The safety profile was consistent with the established profile of Trodelvy.

The National Comprehensive Cancer Network preferred Trodelvy as a treatment option for HR+/HER2-negative breast cancer.

Also read: HS News


GSK announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat) for treating adult patients with chronic kidney disease (CKD). Jesduvroq was a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), a new oral treatment approved for anemia in CKD patients in over 30 years.

The approval was based on the ASCEND-D trial, a randomized open-label Phase 3 trial. The primary endpoint was hemoglobin levels from baseline to week 28 to week 52 and the first occurrence of major cardiovascular events. The mean change in the hemoglobin level from baseline to week 28 through 52 weeks was 0.28±0.02 g/deciliter in Jesduvroq versus 0.10±0.02 g/deciliter in the epoetin alfa group. After the median follow-up of 2.5 years, cardiovascular events were observed in 25.2% of Jesduvroq patients versus 26.7% in the ESA group.

The regulatory approval was under review with the European Medicines Agency. In Japan, it was approved in June 2020 for treating patients with anemia of CKD.


Merck has announced that the US Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) as an adjuvant treatment after surgery and platinum-based chemotherapy. It is approved in patients with stage IB, II, or IIIA non-small cell lung cancer (NSCLC).

The FDA approval was based on the KEYNOTE-091 trial, in which Keytruda demonstrated improvement in disease-free survival versus placebo in NSCLC patients following surgical resection and platinum-based chemotherapy. This is the fifth indication in the NSCLC setting and the 34th overall indication in the US.

In the Phase 3 KEYNOTE-091 trial, investigator-assessed disease-free survival (DFS) is the primary endpoint. Keytruda reduced the risk of disease recurrence or death by 27% versus the placebo. The median DFS was 58.7 months in patients on Keytruda versus 34.9 months in patients on placebo.

Merck announced the safety profile in the KEYNOTE-091 trial is consistent with the existing one.


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