After highlighting the first half of the year in our top decisions from the first half of 2022, Practical Cardiology’s editorial staff fixed its gaze on the cardiology pipeline for the remainder of 2022. In this list, we highlight potential FDA Decisions and trials to watch for in the second half of the year. Of note, due to resubmissions, some items on the list are included due to their original PDUFA dates falling within 2022.
PDUFA Date: Oct. 8, 2022
scPharmaceuticals developed an investigational, proprietary furosemide solution named FUROSCIX, which is formulated to a neutral pH and designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system for outpatient self-administration. In their Q1 2022 Business Update, scPharmaceuticals announced the US FDA’s receipt of their NDA resubmission for FUROSCIX as a treatment for congestion in patients with worsening heart failure. The company noted the FDA had set a PDUFA date of October 8, 2022, and, if approved, expects a commercial launch of the agent in Q4 2022.
PDUFA Date: Nov. 17, 2022
A humanized anti-CD3 monoclonal antibody, teplizumab is being developed by Prevention Bio Inc. The company had received a CRL in July 2021 and announced the resubmission of the BLA for the agent on March 21, 2022. The agent previously had a PDUFA date of August 17, 2022 but this was amended to reflect the FDA’s extension of its review of the BLA, which was announced by the company on June 30, 2022. Potential approval of the agent is backed by results of the Teplizumab Prevention Study, which the company claims is the first trial to show clinical type 1 diabetes can be delayed for a median of two years in children and adults at high risk.
PDUFA Date: Feb. 28, 2023
A selective, small molecule cardiac myosin activator, Cytokinetics announced the submission of their NDA for omecamtiv mecarbil for the treatment of heart failure with reduce ejection fraction in a release on February 04, 2022. Although initially given a PDUFA date of November 30, 2022, this was extended by 3 months to allow for the communication of additional data by request of the FDA, which was announced in a release on June 17. With the resubmission, the updated PDUFA date is February 28, 2023.
Eli Lilly and Company announced their phase 3 randomized, placebo-controlled trial assessing use of empagliflozin in patients with chronic kidney disease, with and without diabetes, would conclude early due to “clear positive efficacy” in a release on March 16. With dapagliflozin demonstrating benefit in this patient population in 2020 with DAPA-CKD, results of the much-anticipated EMPA-KIDNEY trial could provide evidence of a class-effect with SGLT2 inhibitors that goes beyond cardiovascular protection and improving glucose control.
CLEAR Outcomes could prove to be one of the most influential trials in recent years in dyslipidemia. The first oral, non-statin therapy to receive approval from the FDA as a lipid-lowering agent in nearly 20 years, bempedoic acid was approved based on the results of 5 trials within the CLEAR program. A 5-year cardiovascular outcomes trial, CLEAR Outcomes trial was designed to provide insight into the potential reduction in risk of cardiovascular events achieved with use of bempedoic acid. According to Esperion, the company that produces bempedoic acid, the trial is expected to conclude in the second hula of 2022, but there has been no timeline made available publicly on when results will be announced.
Empagliflozin is not the only SGLT2 inhibitor to make headlines with news from a phase 3 trial in the early half of 2022. On May 5, AstraZeneca announced the phase 3 DELIVER trial had met its primary endpoint, with use of dapagliflozin associated with a reduction in risk of cardiovascular death or worsening heart failure in patients with preserved ejection fraction. With this announcement coming on the heels of new ACC/AHA/HFSA guidelines for heart failure, which awarded a Class 2a recommendation for SGLT2 inhibitors in HFmrEF and HFpEF, the results of the trial offer the possibility to conclude whether or not the benefits seen in EMPEROR-Preserved are a class effect with SGLT2 inhibitors.