FDA expands approval of Agios' Tibsovo; AstraZeneca's long-acting diabetes drug secures US nod
→ Tibsovo is Agios’ first wholly-owned product, second approved therapy and the last drug that founder David Schenkein saw across the finish line before handing over the reins to Jackie Fouse. Like the 2017-approved Idhifa, Tibsovo was cleared to treat relapsed or refractory acute myeloid leukemia (AML) — an aggressive form of blood cancer — in patients who carry an IDH1 mutation. On Thursday, the product’s approval was expanded to include adult patients with newly-diagnosed AML with a susceptible IDH1 mutation. “Despite several new AML medicines approved in the last two years, many newly diagnosed patients are still not eligible for existing therapies or combination regimens because of age and other comorbidities,” said Agios $AGIO chief medical officer Chris Bowden said in a statement.
→ AstraZeneca on Friday won US approval for its long-acting diabetes drug, Qternmet XR, which comprises its SGLT2 inhibitor Farxiga, DPP-4 inhibitor Onglyza and metformin hydrochloride, to control high blood sugar. The FDA approval was based on twin late-stage studies. The British drugmaker $AZN already sells different doublet combinations of the main ingredients in Qternmet.
→ With the looming cloud of losing US patent protection for its mega-blockbuster Humira, AbbVie $ABBV needs all the help it can get to fill the gaping $20 billion hole the flagship autoimmune disease drug will leave in its coffers. Last week, the company secured the FDA approval of an IL-23 inhibitor, Skyrizi, that is expected to go some way in replenishing that revenue stream — although that may be difficult in the intensely competitive field it is set to enter. Japan became the first region to sanction the use of Skyrizi last month. And earlier this week, the EU became the third region to sanction the psoriasis drug’s approval.