FDA Updates for the Week of July 10, 2023

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Approvals this week include Opill, the first nonprescription oral contraceptive, the use of Veklury for COVID-19 in patients with severe renal impairment, and the earlier use of Leqvio for in heart disease. In addition, Takeda pulled its application for a dengue vaccine.

FDA Approves First Nonprescription Oral Contraceptive.

The FDA has approved a nonprescription version of the contraceptive Opill (norgestrel). It is the first daily oral contraceptive approved for use in the United States without a prescription. Developed by HRA Pharma, a Perrigo company, the nonprescription Opill consists of 0.075 mg norgestrel and is a progestin-only daily birth control pill, which is also referred to as a mini pill or non-estrogen pill. The prescription Opill is not currently marketed.

Opill will be available in stores and online at leading retailers early in the first quarter of 2024. Pricing information is not yet available; pricing will be available in advance of availability, a company spokesperson said.

FDA Approves Veklury for COVID-19 in Patients with Severe Renal Impairment.

The FDA has approved a supplemental new drug application (sNDA) for the use of Gilead’s Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. Veklury is the antiviral standard of care to treat hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression.

About 37 million people in the United States are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19 related morbidity and mortality.

The new indication is based on the results from a phase 1 study (GS-US-540-9015), as well as the pharmacokinetics (PK) and safety data from the phase 3 REDPINE trial. No new safety signals were observed in either of the studies. The REDPINE study closed prematurely due to feasibility issues and was underpowered to assess for efficacy because of lower-than-expected enrollment. No additional adverse reactions to Veklury were identified.

FDA Approves Leqvio for Earlier Use in Heart Disease.

The FDA has approved a label update for Novartis’ Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease. This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event.

The label for Leqvio has also been updated to remove four adverse events since the frequency of these events were the same as the placebo arm after rounding: urinary tract infection, diarrhea, pain in extremity and dyspnea.

The wholesale acquisition cost of Leqvio is $3,331.76 per dose per injection, which is administered twice a year, after two initial doses. A spokesperson for Novartis indicated that most payers require a prior authorization. With an updated label and broader indication, the company anticipates more appropriate patients will have access to Leqvio.

Takeda Pulls Application for Dengue Vaccine.

Takeda has voluntarily withdrawn the U.S. biologics license application (BLA) for its dengue vaccine candidate, TAK-003. The company indicated in a statement that it could not address issues related to aspects of data collection within the current BLA review cycle. Takeda officials indicated they are evaluating next steps for the vaccine.

Dengue is a mosquito-borne virus that spreads rapidly and is found in tropical climates. It is transmitted through the bite of the Aedes species of mosquito, which also spreads the Zika and chikungungya viruses.

Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus. It was being evaluated by the FDA for the prevention of dengue disease in people 4 years through 60 years of age. The regulatory agency had granted priority review to TAK-003 in November 2022.

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