April 2023 Recap: Drug Pipeline Updates

The table below is a review of notable updates that occurred in April 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Drug	Pharmacologic Class	Proposed Indication	Status
Gastroenterology
Mirikizumab (Eli Lilly)	Anti-IL-23p19 monoclonal antibody	Treatment of ulcerative colitis.	Complete Response Letter issued
Hematological Disorders
Lovo-cel (lovotibeglogene autotemcel; bluebird bio)	Gene therapy designed to add functional copies of a modified form of the β-globin gene	Treatment of sickle cell disease.	BLA submitted
Infectious Disease
Ensitrelvir fumaric acid (Shionogi)	3CL protease inhibitor	Treatment of COVID-19.	Fast Track designation
SAB-176 (SAB Biotherapeutics)	Neutralizing polyclonal immunoglobulin antibody	Treatment of Type A and B influenza illness in high-risk patients.	Fast Track designation
Bemnifosbuvir (Atea Pharmaceuticals)	Nucleotide polymerase inhibitor	Treatment of COVID-19.	Fast Track designation
Musculoskeletal Disorders
RGX-202 (RegenixBio)	Gene therapy designed to deliver a transgene for a novel microdystrophin	Treatment of Duchenne muscular dystrophy.	Fast Track designation
AOC 1044 (Avidity Biosciences)	Monoclonal antibody that binds to the transferrin receptor 1 conjugated with a PMO targeting exon 44	Treatment of Duchenne muscular dystrophy.	Fast Track designation
Ophthalmic Disorders
KPI-012 (Kala Pharmaceuticals)	Mesenchymal stem cell secretome therapy	Treatment of persistent corneal epithelial defect.	Fast Track designation
Oncology
Pembrolizumab (Merck)	Programmed death receptor-1 blocking antibody	In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.	sBLA accepted for review

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