Sunday, February 23, 2020

Sunday, February 23, 2020

HERON THERAPEUTICS: Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)


Heron Therapeutics, Inc. issued the following announcement on Oct. 22.

Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.

CINVANTI is the first and only IV formulation of a substance P/neurokinin-1 (NK1) receptor antagonist (RA) that is free of synthetic surfactants, including polysorbate 80, and that is approved for use as a 2-minute IV injection (also referred to as an IV push). CINVANTI is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly emetogenic cancer chemotherapy (HEC) and MEC. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce CINV in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy).

CINVANTI was initially approved based on data demonstrating the bioequivalence of CINVANTI to EMEND IV® (fosaprepitant), supporting its efficacy for the prevention of acute and delayed CINV following HEC and MEC. Results from two pivotal, randomized, cross-over, bioequivalence studies of CINVANTI and EMEND IV showed subjects receiving CINVANTI reported fewer adverse events than those receiving EMEND IV, including substantially fewer infusion-site reactions. In February 2019, the FDA approved Heron's sNDA to expand the administration of CINVANTI beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection (also referred to as an IV push). This 2-minute IV push for CINVANTI was approved based on a third study demonstrating bioequivalence and a comparable safety profile to CINVANTI given as a 30-minute IV infusion.

The CINVANTI label expansion standardizes the CINVANTI 130 mg single-dose regimen for patients receiving HEC and/or MEC as an injection over 2 minutes or an infusion over 30 minutes, further simplifying dosing and administration and eliminating the need to take oral aprepitant on Days 2 and 3 following MEC administration. Furthermore, this label expansion builds on the prior label expansion that introduced the 2-minute IV push, which enables physicians to leverage the operational advantages of this method of administration and contributes to a reduction in total patient time spent at the infusion site.

"This most recent label expansion to offer a simplified dosing regimen for MEC adds to the important advantages CINVANTI provides to patients as the only FDA-approved, IV NK1 RA available as a convenient 2-minute IV push for MEC and HEC," said Rudolph M. Navari, M.D., Ph.D., University of Alabama, Birmingham School of Medicine, Division of Hematology and Oncology. "The simplified dosing in MEC removes the need for patients to take oral aprepitant on Days 2 and 3, which can improve compliance and reduce costs. These benefits continue to improve the overall patient experience with CINVANTI."

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

Original source can be found here.

Organizations in this Story

Heron Therapeutics

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