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New medicines #49 - April 17, 2021 - April 23, 2021
A weekly overview of the development of new medicines.
- GlaxoSmithKline announced that the FDA approved Jemperli (dostarlimab), for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
- Ocugen announced its partner, Bharat Biotech, released data from a second interim analysis of its Phase 3 trial for its COVID-19 vaccine candidate, Covaxin:
The data exhibited a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease of 100%
Ocugen is eligible of 45% of profits in the US market should it receive marketing approval
- Syndax Pharmaceuticals announced dose escalation data from its phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias:
The overall response rate (ORR) among evaluable patients was 48% (15/31)
- TG Therapeutics announced data from two phase 3 trials, ULTIMATE I & II, evaluating ublituximab compared to teriflunomide, in patients with relapsing forms of multiple sclerosis (RMS):
The company previously announced in December 2020 that both trials met their primary endpoints with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR)
The data to be presented tomorrow at the American Academy of Neurology (AAN) Annual Meeting, noted that in ULTIMATE I, treatment with ublituximab resulted in an ARR of 0.076 compared to 0.188 for teriflunomide, representing a relative reduction of approximately 60% (p<0.0001)
In ULTIMATE II, treatment with ublituximab resulted in an ARR of 0.091 compared to 0.178 for teriflunomide, representing a relative reduction of approximately 50% (p=0.0022)
Source: BPC (reformatted), SY, Bioworld