October 2022 decisions expected from the FDA
Your monthly synopsis of new drugs expected to hit the marketSeptember 12, 2022
Drug pipeline for October 2022:
10/8/2022: Furoscix® (subcutaneous furosemide, sc2Wear furosemide infusor-drug/device combination)
The FDA is evaluating ScPharmaceuticals’ Furoscix for diuresis in patients with worsening heart failure. Furoscix is a wearable formulation of furosemide delivered subcutaneously to allow patients to diuresis at home instead of an IV infusion in the hospital. It is a self-administered pre-programmed drug delivery system. Furoscix is applying for approval via the 505(b)(2) pathway using Pfizer’s Lasix® (furosemide) as its reference drug.1 Similar products include IV furosemide.
10/8/2022: SPN-830 (apomorphine infusion pump)
Supernus Pharmaceuticals’ SPN-830 for continuous treatment of ON-OFF episodes in Parkinson’s disease patients whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. Supernus originally submitted the NDA for SPN-830 in September 2020 but the FDA issued a refusal to file (RTF) letter stating that the application was not sufficiently complete to permit a substantive review. The application included data from the Phase 3 TOLEDO study and a supportive open-label study. SPN-830 demonstrated a 2.47 hours per day reduction in OFF time compared to placebo.2 Similar products include generic apomorphine.
The FDA granted priority review to AstraZeneca’s tremelimumab for treatment of patients with unresectable hepatocellular carcinoma (HCC). HCC is the most common type of liver cancer. In the U.S. roughly 26,000 people are diagnosed with it annually. Liver cancer is the third-leading cause of cancer death worldwide. Tremelimumab is an anti-CTLA4 antibody used as a single priming dose in combination with the PD-L1 inhibitor AstraZeneca’s Imfinzi® (durvalumab) in the STRIDE regimen for dual immune checkpoint blockade. The BLA is based on results of the Phase 3 trial that showed STRIDE achieved a 22% reduction in the risk of death compared to Bayer’s Nexavar® (sorafenib). After three years, 31% of those on STRIDE were still alive compared to 20% for the Nexavar group.3 Similar products include Genentech’s Tecentriq® (atezolizumab) + Avastin® (bevacizumab).
10/29/2022: cipaglucosidase alfa (with miglustat)
The FDA is reviewing Amicus Therapeutics’ cipaglucosidase in combination with miglustat for the treatment of patients with Pompe disease. Pompe is a very rare disease, with an estimated incidence of 1 in 20,000 to 100,000 births and a worldwide prevalence of 5,000 to 10,000 individuals. The two-component therapy for Pompe disease is comprised of the intravenous (IV) enzyme-replacement therapy (ERT) cipaglucosidase alfa co-administered with the oral molecular chaperone miglustat cipaglucosidase alfa. An enhanced version of the standard of care, Sanofi’s Lumizyme® (alglucosidase alfa), contains modifications in the protein backbone and in the surface glycosylation pattern to reduce immunogenicity and to enhance targeting to key affected muscles. The PROPEL trial compared the safety and effectiveness of AT-GAA to Lumizyme, the current standard Pompe treatment. Cipaglucosidase alfa did not meet the primary endpoint of the study of the six-minute walk test (6MWT) when comparing the group given AT-GAA with the ERT-naive group receiving the current standard of care, alglucosidase alfa.4 Similar products include Lumizyme® and Nexviazyme®.
While the information in this article is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.
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