July 2023 decisions expected from the FDA

At Prime Therapeutics (Prime), we’ve positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on drugs likely to be approved by the U.S. Food and Drug Administration (FDA).

Drug pipeline for July 2023:

7/1/2023: glofitamab
The FDA has granted priority review to Roche’s glofitamab for relapsed or refractory large B-cell lymphoma after patients have tried other therapies. Glofitamab will be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with aggressive lymphoma for people who have already tried other methods of treatment. Glofitamab is seeking approval based on the Phase 1/2 NP30179 study, which demonstrated that 40.0% of patients achieved a complete response (CR; a disappearance of all signs of cancer), and 51.6% achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body). The median follow-up time was 13.4 months.¹ Similar products include CAR-T cell therapy.

7/5/2023: Beyfortus^® (nirsevimab)
AstraZeneca’s Beyfortus is seeking approval from the FDA for the prevention of respiratory syncytial virus (RSV) in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus is seeking approval based on data including the MELODY Phase 3, MEDLEY Phase 2/3, and Phase 2b trials. These trials demonstrated a reduction in the incidence of medically-attended lower respiratory tract infections (LRTI) caused by RSV by 74.5% compared to placebo through day 151 (a typical RSV season) with a single dose.² Similar products include Sobi’s Synagis^® (palivizumab).

7/6/2023: rozanolixizumab
The FDA has granted priority review to UCB’s rozanolixizumab for treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab is a neonatal Fc receptor (FcRn)-targeting monoclonal antibody for subcutaneous injection. Rozanolixizumab is seeking approval based on the Phase 3 MycarinG study, in which rozanolixizumab demonstrated statistically significant and clinically meaningful improvements in MG-specific outcomes in patients with AChR MuSK antibody positive MG. In the primary endpoint, rozanolixizumab significantly reduced MG-ADL from baseline to Day 43 with a LS mean difference vs placebo (95% CI) of -2.59 points at the 7mg/kg dose and -2.62 points at the 10mg/kg dose.³ Similar products include Argenx’s Vyvgart^® (efgartigimod alfa-fcab).

 7/24/2023: Ycanth^® (cantharidin 0.7% topical solution)
Verrica Pharmaceuticals’ Ycanth is being reviewed by the FDA as a drug-device combination for topical treatment of molluscum contagiosum. Molluscum contagiosum is a highly contagious viral skin infection that affects close to 6 million people in the United States each year. Cantharidin is currently available as a compounded agent. Verrica Pharmaceuticals is seeking FDA approval based on the Phase 3 CAMP trial that demonstrated Ycanth to be statistically significant when compared to placebo. Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location (head, chest, back, groin, upper and lower extremities) by day 84 compared to vehicle.⁴ When used on patient’s head/neck, 81.8% of Ycanth patients experienced complete clearance compared to 39.6% with vehicle. Overall, 50% of patients using Ycanth experienced complete clearance compared with 15.6% response with use of the vehicle. Verrica Pharmaceuticals intends to conduct additional clinical trials later this year to evaluate Ycanth for treatment of common warts and external genital warts. Similar products include cryotherapy, cantharidin compounded solution, and Allergan Pharmaceuticals’ Condylox^® (podofilox).

7/24/2023: quizartinib
Daiichi Sankyo’s quizartinib has been granted priority review by the FDA for treatment of adults with newly diagnosed acute myeloid leukemia (AML) that are FLT3-ITD positive. Quizartinib is an oral, selective type II FMS-like tyrosine kinase 3 (FLT3) inhibitor for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation. Quizartinib is seeking approval based on the Phase 3 QuANTUM-First study that achieved a statistically significant overall survival (OS) rate. In QuANTUM-First, quizartinib combined with standard induction and consolidation chemotherapy and then continued as a single agent in newly diagnosed FLT3-ITD positive AML demonstrated a 22.4% reduction in the risk of death compared to standard chemotherapy alone. After a median follow-up of 39.2 months, median OS was more than double at 31.9 months for patients receiving quizartinib compared to 15.1 months for patients receiving chemotherapy.⁵ Similar products include Novartis’ Rydapt^® (midostaurin).

7/28/2023: RiVive^® (naloxone 3mg nasal spray)
Harm Reduction Therapeutics’ RiVive is seeking approval from the FDA as an over the counter (OTC) product of the opioid antagonist formulated as a 3mg nasal spray for treatment of a known or suspected opioid overdose emergency. Based on provisional Centers for Disease Control and Prevention data, over 107,000 overdose deaths occurred in the 12-month period ending in August 2022.⁶ RIVive is seeking approval through the 505(b)2 pathway using Emergent’s Narcan^® (naloxone) as its reference product.

Contact your Prime representative for more information or with any questions you have about drugs in the pipeline.

References

1. https://www.gene.com/media/press-releases/14980/2023-01-05/fda-grants-priority-review-to-genentechs
2. https://www.astrazeneca.com/media-centre/press-releases/2023/nirsevimab-us-regulatory-submission-accepted-for-the-prevention-of-rsv-lower-respiratory-tract-disease-in-infants-and-children.html
3. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-rozanolixizumab-BLA-for-the-treatment-of-generalized-myasthenia-gravis-filed-with-US-FDA-and-designated-for-Priority-Review
4. https://verrica.com/press_release/fda-accepts-resubmitted-filing-for-vp-102-for-the-treatment-of-molluscum-contagiosum/
5. https://www.cancernetwork.com/view/fda-grants-priority-review-to-quizartinib-for-newly-diagnosed-flt3-itd-aml
6. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-cders-continued-efforts-widen-naloxone-access