Setback For Alembic-backed Rhizen After Concerns Over PI3K Inhibitors
Disappointment for Alembic-backed Rhizen after partner TG Therapeutics takes Ukoniq off the US market amid wider regulatory scrutiny around the PI3K inhibitor class of drugs. The Indian firm, however, remains upbeat about the US business, which saw significant growth in the fiscal fourth quarter and has15-plus launches lined up.
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Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.
TG Therapeutics is withdrawing the PI3K-delta inhibitor from the market and halting enrolling in other umbralisib oncology studies to focus attention on ublituximab in relapsing multiple sclerosis.
Rhizen is entitled to royalties on net sales of US FDA-approved Ukoniq, being commercialized by partner TG Therapeutics, and expects to take the lymphoma treatment to India. CEO suggests the first-in-class PI3K/CK1 epsilon inhibitor, discovered by Rhizen, bests competitors including Bayer's Aliqopa.