FDA plans to approve drug reports in May

CompileKe Ke

May is an extremely busy month on the FDA's new drug review calendar.

Heron Therapeutics: New drug HTX-011 for postoperative pain

The target action date for the New Drug Application Application (NDA) of HTX-011 for the treatment of postoperative pain is May 12, 2021.

HTX-011 is a non-opioid analgesic, a dual-acting, fixed-dose combination of local anesthetic bupivacaine and low-dose non-steroidal anti-inflammatory meloxicam.

In September 2020, the European Commission (EC) granted HTX-011 a marketing authorization for drugs marketed under the Zynelef brand for somatic postoperative pain in adult small and medium surgical wounds.

Apellis Pharma: Pegcetacoplan for paroxysmal nocturnal hemoglobinuria (PNH)

The Apellis drug has a target action date of May 14 for the treatment of PNH, a rare blood disease that causes red blood cells to divide (hemolysis).

On December 10, 2020, Apellis and Sweden’s SOBIO Biovitrum AB announced the positive top-line results for the 48th week of the Phase 3 clinical study Pegasus.

Sanofi: A new drug for Pompe disease (Avalglucosidase Alfa)

Sanofi's new drug has a biological preparation license application (BLA) target date of May 18 for long-term enzyme replacement therapy for patients with Pompe disease.

In early February 2021, at the 17th WORLDSymposium conference, Sanofi released data supporting the BLA.

Bristol-Myers Squibb (BMS): Opdivo adjuvant treatment of esophageal cancer or gastroesophageal junction cancer

BMS’s target date of action is May 20, and its supplementary BLA is used for Opdivo (nivolumab) to treat neoadjuvant chemoradiotherapy (CRT) after adjuvant treatment of patients with resection of the esophagus or gastroesophageal junction (GEJ) cancer.

This application is based on the positive results of the Phase 3 clinical trial CheckMate-577.

ADC Therapeutics: new drug Lonca for diffuse B-cell lymphoma

The BLA target action date for Lonca (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is May 21.

The US FDA approved Lonca on April 23, 2021 for patients with r/r large C-cell lymphoma who have received two or more systemic treatments, including DLBCL, non-other specific lymphoma (NOS), and DLBCL caused by low-grade lymphoma, and high-grade B-cell lymphoma.

Reference source: FDA Action Alert: Heron, Apellis, Sanofi, Merck and ADC