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FDA-approved Drugs of Interest to Underwriters: Recent and Relevant Therapeutics

Our clinical team continually updates our SaaS tools so you can confidently assess mortality or morbidity risk, even when you’re seeing a new therapeutic for first time. This page highlights recent FDA approvals – bookmark it and check back regularly for insights into drugs that our clinical consultants find particularly noteworthy.

First oral agent for the treatment of postpartum depression: Zurzuvae (zuranolone)

—December 15, 2023
Kim Sapre
Kimberly Sapre, Medical Consultant

Zurzuvae (zuranolone, approved August 2023) is a once-daily oral treatment given for one 14-day course for postpartum depression, the first oral agent approved by the FDA for this condition. While its mechanism is not fully understood, it is thought zuranolone functions similarly to the previously approved intravenous therapy for postpartum depression, Zulresso (brexanolone), by increasing the binding of GABA-A receptors in the brain to reduce symptoms of depression. Subjects in clinical trials saw improvement in symptoms in as little as three days, which is much quicker than most antidepressants on the market that work on different receptors in the brain.

Postpartum depression can be diagnosed during pregnancy, but it is more frequently diagnosed after delivery. Underwriters may expect to see fills of the medication on the applicant’s profile following delivery, but there should only be one 14-day course of the medication. Furthermore, other antidepressants (e.g., sertraline) may be prescribed in conjunction with or prior to the administration of zuranolone.

As an oral agent, Zurzuvae fills will show up in Prescription Data. Anticipated relative mortality: Low (< 100%)

A new agent to prevent symptomatic heart failure and cardiovascular death: Inpefa (sotagliflozin)

—December 15, 2023

Underwriters may expect to see this medication prescribed after a recent hospitalization or an emergency department visit for the treatment of acute heart failure, or in those with the risk factors indicated above. Sotagliflozin will usually appear on an applicant’s profile after other medications that are used to treat heart failure and / or diabetes, such as beta blockers (e.g., carvedilol, metoprolol), hypertension medications (e.g., lisinopril, losartan), diuretics (e.g., furosemide, spironolactone), diabetes medications (e.g., metformin, semaglutide), etc. Finding sotagliflozin on the profile likely signals worsening of disease or, at a minimum, concern for cardiovascular problems in those with these significant risk factors.

While sotagliflozin is approved for the treatment of type 1 diabetes in some parts of Europe, safety concerns have prevented its approval by the FDA for that condition in the United States at this time.

Because it’s an oral agent, underwriters will spot Inpefa fills in Prescription Data. Anticipated relative mortality: High (>220%)

Kim Sapre
Kimberly Sapre, Medical Consultant


A new infusion for the treatment of Alzheimer’s disease: Leqembi (lecanemab-irmb)

—December 15, 2023

Leqembi (lecanemab-irmb, approved January 2023) is an intravenous infusion given every two weeks for the treatment of early Alzheimer’s disease. Similar to Aduhelm (aducanumab-avwa, approved June 2021), lecanemab works by reducing the build-up of beta-amyloid plaques in the brain, one of the primary causes of Alzheimer’s disease responsible for impairing the brain cell’s functionality. In clinical trials, lecanemab was shown to only modestly slow both cognitive decline and loss of ADL (activities of daily living) function when compared to placebo. While it may slow or delay symptoms, it does not cure or reverse Alzheimer’s disease and is not approved for those with severe disease.

Underwriters may expect to see this medication used in those with early forms of Alzheimer’s disease; however, based on the population who participated in clinical trials, eligibility to use the product may be limited. Additionally, its biweekly administration in a clinic or hospital as well as its high list price of around $26,000 per year may further limit its use when cheaper, more convenient options (e.g., donepezil, memantine) are already available on the market.

As an intravenous infusion, Leqembi will found in Medical Data. Anticipated relative mortality: Medium (180-220%)

Kimberly Sapre, Medical Consultant
Kim Sapre