10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are already 26 novel drug approvals (at time of writing), for half way through the year this is already a staggering number, showing just how successful the investments into innovations are in the industry.
In this article we highlight 10 of the most recent novel drug approvals, covering a variety of fields of medicine, including migraines and menopause, to cancer drugs. We’ll also give an update on some of the drugs we marked at the end of 2022 as ‘ones to watch’, to see how they are progressing in the approval process.
Including cardiovascular medicine, medicines for conditions of the CNS, and those specifically for women’s health, there have been some major approvals already in 2023.
May 2023 - Inpefa – Lexicon Pharmaceuticals gains approval for Inpefa, their SGLT1/SGLT2 inhibitor. The drug is approved for used in adults diagnosed with heart failure, type 2 diabetes mellitus, chronic kidney disease, and other conditions leading to a greater risk of cardiovascular disease.
May 2023 - Veozah – The new treatment for moderate to severe vasomotor symptoms – hot flashes caused by menopause – from Astellas Pharma has been approved in a 45 mg once a day dosage. The medication has been studied in over 3,000 patients from three Phase III clinical trials across the USA, Canada, and Europe. Veozah restores temperature moderation in the body by blocking neurokinin B in the temperature control centre.
March 2023 – Zavzpret is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine in adults. The nasal spray was tested in a Phase III clinical trial on patients with migraines with or without auras, and compared to a placebo. The spray is the first-of-its-kind treatment from Pfizer, revolutionising the field.
February 2023 - Skyclarys – Reata Pharmaceuticals gained approval for its first drug application in the company’s history, with its oral, daily dosage form for the treatment of Friedreich’s ataxia. The efficacy and safety of Skyclarys was evaluated in a 48-week randomised, placebo-controlled, and double-blind study, Study 1 (NCT02255435) including 103 patients, and an open-label extension. The FDA granted Orphan Drug, Fast Track, and Rare Paediatric Disease Designations for the medication, and the European Commission also granted Orphan Designation.
January 2023 - Brenzazzy – TheracosBio received FDA approval for their oral SGLT2 inhibitor for use as supplementary to exercise and dietary improvements for glycaemic control in patients with type 2 diabetes. The approval comes after the safety and efficacy of the drug was tested in 23 clinical trials involving over 5,000 adults with type 2 diabetes. It will prove an important option for those suffering with the disease.
Although there has been a winding down in production of strictly novel COVID-19 medicines, a field that effectively dominated the innovation space for the past few years, some medicines that we are familiar with already have gained full approval just recently.
May 2023 - Paxlovid – a drug name from Pfizer we’ve heard countless times over the last couple of years, as a treatment for COVID-19 in adults at risk of progression to severe disease, but the drug was only previously approved under the emergency use protocol, now it receives full and comprehensive FDA approval.
Due to some recent advances in oncology, new drugs for cancer therapies have been emerging, to be used either on their own or in conjunction with other treatments. Generally these drugs are intended for use after first- or second-line treatments have failed.
May 2023 – Epkinly – The now well-known cancer drug from AbbVie is approved for use in treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Epkinly is a bispecific CD20-directed CD3 T-cell engager, designed to bind to CD3 on T-cells and CD20 on B-cells, and induce the death of CD20+ cells by killer T-cells. The revolutionary treatment is delivered via subcutaneous injection.
March 2023 – Zynyz – The US FDA approved the use of Zynyz from Incyte, for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma. The immune-checkpoint inhibitor, specifically a humanised, hinge-stabilized IgG4k antibody targeting PD-1, was tested in the Phase II POD1UM-201 trial (NCT03599713), an open-label, multiregional, single-arm study, carried out with 65 patients with Merkel cell carcinoma.
January 2023 – Orserdu – From Stemline Therapeutics gained approval for use in postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, along with disease progression, having received a minimum of one line of endocrine therapy previously. The study that led to the approval was a randomized, open-label, active-controlled, multicenter trial called EMERALD (NCT03778931), which included 478 patients. The recommended dose is 345 mg to be taken orally with food once every day until disease progression or unacceptable toxicity is reached. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer | FDA .
January 2023 – Jayprinka – The covalent BTK-inhibitor (pirtobrutinib) from Eli Lilly was undergoing an open-label, multicenter, single-arm trial of pirtobrutinib monotherapy (BRUIN) when it was approved by the FDA. The study was based on 120 patients with relapsed or refractory mantle cell lymphoma having had at least two lines of systemic therapy, including a BTK inhibitor, making up the criteria the drug is approved for. The drug is administered in a 200 mg dose taken orally, once a day.
2022 'Ones to watch' updated
Leqembi – Received final approval from the FDA in January 2023 after clinial trials results showed that it reduced the amyloid plaques in the brain, which are the main markers of disease. Approval is granted under Fast Track, Priority Review and Breakthrough Therapy designations.
Donanemab from Eli Lilly shows promising results in further trials, after an initial roadblock in January. The TRAILBLAZER-ALZ 2 Phase III trial demonstrated that patients showed a clinical decrease in disease progression and cognitive decline by 35% when compared to placebo. The promising results set the drug up well looking forward to approval applications.
Trodelvy® – initially approved in 2021 has received full approval after further review in February 2023.
Fierce Pharma. Lexicon finally scores FDA nod for heart failure drug Inpefa. [Date accessed 21/06/2023]. www.fiercepharma.com/pharma/lexicon-secures-elusive-fda-nod-heart-failure-drug-inpefa
US Food and Drug Administration. FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause. [Date Accessed 21/06/2023]. www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause
Pfizer. Pfizer’s ZAVZPRET™ (zavegepant) Migraine Nasal Spray Receives FDA Approval. [Date Accessed 22/06/2023]. www.pfizer.com/news/press-release/press-release-detail/pfizers-zavzprettm-zavegepant-migraine-nasal-spray
US Food and Drug Administration. FDA approves first treatment for Friedreich’s ataxia. [Date Accessed 22/06/2023]. www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia
Businesswire. TheracosBio Announces FDA Approval of Brenzavvy™ (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes. [Date Accessed 21/06/2023]. www.businesswire.com/news/home/20230123005126/en/TheracosBio-Announces-FDA-Approval-of-Brenzavvy%E2%84%A2-bexagliflozin-for-the-Treatment-of-Adults-with-Type-2-Diabetes
Pfizer. Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19. [Date Accessed 21/06/2023] www.pfizer.com/news/press-release/press-release-detail/pfizers-paxlovidtm-receives-fda-approval-adult-patients
US Food and Drug Administration. FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma. [Date Accessed 22/06/2023]. www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-zynyz-retifanlimab-dlwr-metastatic-or-recurrent-locally#:~:text=On%20March%2022%2C%202023%2C%20the,locally%20advanced%20Merkel%20cell%20carcinoma.
Drugs. Epkinly FDA Approval History. [Date Accessed 26/06/2023]. www.drugs.com/history/epkinly.html
US Food and Drug Administration. FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. [Date Accessed 26/06/2023]. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-elacestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer
US Food and Drug Administration. FDA D.I.S.C.O. Burst Edition: FDA approvals of Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma, and Orserdu (elacestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. [Date Accessed 26/06/2023]. www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-jaypirca-pirtobrutinib-relapsed-or-refractory-mantle-cell
US Food and Drug Administration. FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. [Date Accessed 27/06/2023]. www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
Lilly Investors. Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. [Date Accessed 27/06/2023]. https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional
CPHI Online. Roche gains accelerated approval from the FDA for latest cancer therapy. [Date Accessed 28/06/2023]. www.cphi-online.com/roche-gains-accelerated-approval-from-the-fda-for-news121240.html
Ardena and RiboPro have formed an alliance to boost their respective skills in manufacturing and producing nanoparticle and mRNA-based therapeutics to improve accessibility to this technology in the biotherapeutic landscape.
Samsung Biologics agrees to use their biocampus Plant 4 for the manufacture of a line of products from Pfizer.
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors stateDoctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients.
News Soft capsule technology: modified pea starch as a vegetal origin alternative to gelatin in capsule shellThe latest soft capsule technology from Roquette using modified pea starch as an alternative to gelatin.
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