TG Therapeutics’ ublituximab tops Sanofi’s Aubagio in MS trial
19th April 2021
New York-headquartered biopharma company TG Therapeutics has revealed new data for its investigational therapy ublituximab, which demonstrated superiority over Sanofi’s Aubagio in patients with relapsing forms of multiple sclerosis (MS).
The data, from the Phase III ULTIMATE I & II studies, evaluated ublituximab – a novel glycoengineered anti-CD20 monoclonal antibody – in patients with RMS.
Both studies hit their primary endpoint, with ublituximab treatment demonstrating a statistically significant reduction in the annualised relapse rate (ARR) over a 96-week period compared to Aubagio (teriflunomide).
In the ULTIMATE I trial, ublituximab treatment resulted in an ARR of 0.076 compared to 0.188 for Aubagio – a relative reduction of approximately 60%.
Rhizen Pharmaceuticals (associate company of Alembic Pharmaceuticals) announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics (NASDAQ: TGTX), has secured US FDA accelerated
approval for the treatment of:
- adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received
at least one prior anti-CD20 based regimen, and
- adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least
three prior lines of systemic therapy.
Accelerated approval was granted for these indications, under a priority review (MZL), based on the
results of the Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49% with 16% complete
Rhizen s cancer drug Umbralisib gets USFDA nod: Alembic Pharma
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Last Updated: Feb 09, 2021, 12:33 PM IST
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Synopsis
Alembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG s product Umbralisib, which was licensed to TG Therapeutics, has received approval from the US health regulator the drug for the treatment of certain forms of cancer.
Alembic Pharma on Tuesday said its associate company Rhizen Pharmaceuticals AG s product Umbralisib, which was licensed to TG Therapeutics, has received approval from the US health regulator the drug for the treatment of certain forms of cancer.
In a regulatory filing, Alembic Pharma said Rhizen Pharmaceuticals Umbralisib, which was licensed to TG Therapeutics has secured the United States Food and Drug Administration (USFDA) accelerated approval for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) and Follicular Lymphoma (FL).