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FDA Updates for Week of Nov. 8, 2021


President Biden nominates new FDA commissioner, and the agency has approved a liquid form of a seizure medication and a new treatment for a rare blood disease. The FDA also accepted a supplemental NDA for Jardiance this week.

President Biden nominates Robert Califf as FDA commissioner.

Robert M. Califf, M.D.

Robert M. Califf, M.D.

President Joseph Biden has nominated Robert M. Califf, M.D., vice chancellor for clinical and translational research at Duke University, as commission of the FDA.

“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.

Califf has four decades of experience as a doctor, researcher, leader, and was FDA commissioner from February 2015 to January 2016.

Janet Woodcock, M.D., a long-time leader at the agency, has been serving as acting commissioner since January 2021. Before that, she served as director of the FDA’s Center for Drug Evaluation of Research.

FDA approves liquid formulation of seizure medication.

The FDA has approved Azurity Pharmaceuticals’ Eprontia (topiramate), an oral solution that is used as a monotherapy and as adjunctive therapy for patients two years of age and older with partial-onset or primary tonic-clonic seizure, as well as to prevent seizures. Eprontia 25 mg/mL is a ready to use liquid medication for those who have trouble swallowing pills.

Azurity acquired Eprontia and two other neurology products, lamotrigine and zonisamide, from Eton Pharmaceuticals in February 2021. Eton developed the products, which are liquid formulations are to treat seizure. Both are under review at the FDA.

Azurity will be responsible for commercialization. Eton will receive a $5 million milestone payment upon launch of Eprontia, a royalty on net sales, and potential commercial milestones.

FDA approves treatment for rare blood disease.

The FDA has approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.

Besremi, which was developed by PharmaEssential, is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera.

FDA accepts supplemental NDA for Jardiance.

Boehringer Ingelheim and Eli Lilly have submitted a supplemental NDA for Jardiance (empagliflozin) as a treatment to reduce the risk of cardiovascular death for heart failure in adults with left ventricular ejection fraction (LVEF).

The submission is based on the results from the EMPEROR-Preserved phase 3 trial, in which Jardiance was associated with a 21% relative risk reduction (3.3% absolute risk reduction) for the composite primary end point of cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF over 40% compared with placebo. Results were independent of ejection fraction or diabetes status.

Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine.

The FDA has granted the application priority review. In September 2021, the FDA also granted breakthrough designation to Jardiance treatment for adults with heart failure with preserved ejection fraction (HFpEF). HFpEF accounts for about half of the more than 6 million heart failure cases in the United States. No currently approved treatments have been shown to improve outcomes for people with HFpEF.

Jardiance is currently approved to reduce the risk of cardiovascular death for heart failure in adults with heart failure and reduced ejection fraction.

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