The United States Food and Drug Administration (FDA) receives numerous New Drug Applications (NDAs) and Biologic License Applications (BLAs) submissions each year. However, the agency averaged about 40 novel drug approvals annually between 2011 and 2020, with a total of only 410 therapies reaching the market during that period. Although certain review tracks, like Priority Review and Fast Track, can help increase the chances of approval, considering such designations are only granted when a drug has the potential to significantly advance medical care. With the start of a new year upon us, which new therapeutics are coming up on the horizon? Read on to find out the top five drug approvals anticipated for 2023!
Anticipated 2023 Drug Approvals
1 | Rozanolixizumab
Drug: Rozanolixizumab
Company: UCB
Indication: Generalized Myasthenia Gravis
Expected Decision Date: Q2 2023
On January 6, 2023, the FDA accepted UCB’s BLA for rozanolixizumab, a humanized monoclonal antibody that targets human neonatal Fc receptor (FcRn), and granted it Priority Review for the treatment of adults with generalized myasthenia gravis (gMG). gMG is an unpredictable chronic autoimmune neurological disease that weakens muscle contractions in patients. Based on UCB’s pivotal Phase III MycarinG study (NCT03971422), the rozanolixizumab group experienced significant improvements in MG-specific outcomes compared with the placebo arm by Day 43. If approved, rozanolixizumab will become the first treatment available to help improve the debilitating disease burden caused by gMG.
2 | Brexpiprazole
Drug: Brexpiprazole
Company: Otsuka Pharmaceutical and H. Lundbeck A/S
Indication: Agitation associated with Alzheimer’s Dementia (AAD)
Expected Decision Date: May 10, 2023
The supplemental NDA for brexpiprazole, an atypical antipsychotic already approved for schizophrenia, was assigned under Priority Review by the FDA on January 7, 2023, for the treatment of agitation experienced by Alzheimer’s disease (AD) patients. Otsuka and Lundbeck partnered up in two Phase III studies (Study 331-12-283 and Study 331-14-213), which demonstrated brexpiprazole was statistically more effective than placebo in reducing clinical agitation scores between baseline and week 12. Symptoms of agitation are a significant disabling neuropsychiatric feature of AD and one with few treatment options for affected individuals. The approval of brexpiprazole has the potential to improve the health outcomes of not only these AAD patients, but also their health caregivers.
3 | Tirzepatide
Drug: Tirzepatide
Company: Eli Lilly
Indication: Weight Loss
Expected Decision Date: Q2 2023
Tirzepatide, a glucagon-like peptide 1 (GLP-1) agonist, has already been cleared for use in type 2 diabetes mellitus patients, however, there is considerable excitement around the anticipation of its potential approval by the FDA for weight loss in 2023. Lilly’s tirzepatide helped obese or overweight patients lose nearly 22.5% of their body weight by Week 72 in the Phase III SURMOUNT-1 clinical trial. If approved, tirzepatide is expected to net Eli Lilly a record amount in annual sales, estimated to be between $25 billion to $48 billion.
4 | Glofitamab
Drug: Glofitamab
Company: Genentech
Indication: Relapsed or Refractory Large B-cell Lymphoma (LBCL)
Expected Decision Date: Jul 2023
On January 6, 2023, Genentech announced that the FDA had granted Priority Review and Fast Track designation for their glofitamab BLA. Glofitamab is a novel bispecific antibody that engages T-cells of the immune system to treat adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). LBCL is one of the most prevalent cancers in the US and is an aggressive subtype of non-Hodgkin lymphoma that progresses quickly. In the pivotal Phase I/II NP30179 study, patients receiving glofitamab demonstrated a sustained response rate, with 40% achieving a complete response. If approved, glofitamab will be the first fixed-duration treatment available to R/R LBCL patients who have not responded to prior therapy.
5 | RiVive
Drug: OTC Naloxone
Company: Harm Reduction Therapeutics
Indication: Opioid Overdose
Expected Decision Date: Apr 2023
Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company, announced on December 26, 2022, that the FDA had accepted and granted Priority Review to their NDA for RiVive. RiVive is an over-the-counter (OTC) naloxone nasal spray that demonstrated robust Phase I clinical trial results for the reversal of opioid overdose. The ongoing opioid epidemic in North America is a devastating public health crisis, with 200 Americans passing away from overdoses daily. If approved, RiVive will provide a more affordable, immediate alternative to pharmacy-supplied naloxone kits for easy emergency use by laypeople.
Enlist a CRO for Your Next Clinical Trial
What is a CRO and how can they help with drug approvals? CRO is the acronym for contract research organization or clinical research organization. A CRO’s main purpose is to provide assistance to biotech, pharmaceutical, and medical device manufacturers with clinical research services on a contract basis for therapeutic drug development. CROs like IQVIA, PPD, Innovaderm, Medpace, and Vial help scientists, investigators, and drug developers manage clinical trials from end to end. Enlisting a CRO to manage clinical trials can increase a sponsor’s chance of drug approvals from the FDA. CRO services specialize in biostatistical advice, management of regulatory affairs, or pharmacovigilance, and may provide a full range of services for clinical trial management from the selection of clinical sites and investigators to supporting patient recruitment, safety surveillance, clinical monitoring, site audits, project management, data management, and biostatistics.
Vial CRO’s mission as a modern, next-generation CRO is to support sponsors around the globe with our innovative tech-enabled study services to help sponsors get new therapies to market. To learn more about how our products can help your clinical trial reach its full potential and help your next therapy receive drug approval, connect with a team member today!
