The Biggest Drug Approvals of 2022

A carefully curated list of the most notable drug approvals of the past year, covering neurology, oncology, and COVID-19, as well as a look at the most promising drugs up for review in 2023. 

As research efforts have been redoubled in all fields of medicine, we have seen approvals gained across the world for drugs for the treatment of Alzheimer’s disease, depression, diabetes, and cancer. The following list covers many of the key approvals from 2022 as well as notable drugs to watch coming into 2023. 

General medicine 

March 2022 – UCB SA, a Belgian biotech firm gained approval from the US FDA for its drug Fintepla for the treatment of seizures associated with a form of childhood epilepsy called Lennox-Gastaut Syndrome.

June 2022 – Priorix, the vaccine for measles, mumps, and rubella (MMR) from GSK is approved for use in the US in children aged one year and above. Outbreaks of measles have risen in recent years, highlighting the need for further vaccination of children. 

August 2022 – Axsome therapeutics launches its treatment for depression after FDA approval. Auvelity targets neurotransmitters in the brain and is used to treat major depressive disorder. It can be taken in pill form without in situ medical supervision, improving patient compliance.  

September 2022 – A novel treatment for ALS in adults is approved. The drug, Relyvrio, from Amylyx Pharmaceuticals is an oral, fixed dose combination therapy, which had been tested in the CENTAUR clinical trial – a multicentre Phase II clinical trial. The results of the trial showed that Relyvrio made a significant impact in slowing the loss of physical function in adults with ALS. 

November 2022 – Novel diabetes drug teplizumab, under the brand name Tzield, has been approved for use as a first line treatment to delay the onset of type 1 diabetes. The drug from Provention Bio is a monoclonal antibody that works by suppressing the body’s immune response, giving it time to produce more insulin. By delaying the onset of type 1 diabetes, it delays the need for the patient to have regular insulin injections to manage their care. 

December 2022 – The FDA approves a novel antiretroviral medication to treat patients with HIV-1 who have had previously unsuccessful treatments due to resistance, intolerance, and other safety concerns. The drug, Sunlenca, is the first of a new class of drugs – capsid inhibitors – to gain approval for treatment of HIV after showing HIV RNA suppression in 83% of patients 52 weeks after treatment in a multicentre clinical trial. 

Oncology

February 2022 – Johnson & Johnson announce that the US FDA approves their CAR-T therapy Carvykti™ for use in the treatment of relapsed or refractory multiple myeloma in adults who have previously had four or more therapies. On testing in the CARTITUDE-1 study the drug demonstrated durable responses in 98% of patients. 

March 2022 – The anti-PD-1 therapy, Keytruda, from Merck was approved as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and are still experiencing disease progression after previous therapy attempts and are not candidates for surgery or radiation therapy. Merck are also currently seeking patents for the latest version of the drug. 

June 2022 – Novartis gains US approval for their combination therapy, made up of Tafinlar and Mekinist. The drug combination is used to treat inoperable or metastatic tumours in people (including children from 6 years of age) with a genetic mutation, BRAF V600. 

August 2022 - AstraZeneca and Daiichi Sankyo gain EU and US FDA approval for their breast cancer therapy, Enhertu for broadened use to treat HER2-low breast cancer. The antibody-drug conjugate at the lower dose led to the reduction in size of tumours in 58% of patients. 

November 2022 – AstraZeneca and MSD (aka Merck) had their drug Lynparza approved by the European Commission based on results from the PROpel Phase III trial, where the PARP inhibitor when used in combination with abiraterone and prednisone or prednisolone showed reduced risk of disease progression or death compared to previous treatments. 

COVID-19 

January 2022 – US FDA gives full approval for Moderna’s COVID-19 vaccine, Spikevax, for use in people aged 18 and older, after having the vaccine approved only for emergency use since 2020. 

March 2022 – South Korea gives emergency use approval for Merck’s experimental COVID-19 treatment pill, Molnupiravir, the second oral anti-viral medication to be approved in the country. 

April 2022 – the COVID-19 drug remdesivir from Gilead Sciences gains approval for use in children under 12 years of age from US regulators.

August 2022 – UK regulator MHRA approves Moderna’s bivalent vaccine booster for the Omicron strain of COVID-19. 

Ones to watch in 2023 

Alzheimer’s drug Lecanemab – after the Phase III trial conducted that showed promising results for the drug, and after some safety concerns, Lecanemab is set for imminent approval. 

Eli Lilly’s other Alzheimer’s drug Donanemab, currently undergoing Phase III trials. The company is keen to push for FDA review for approval in the next year. 

Trodelvy® - initially approved in 2021, is to come under review in February 2023 to evaluate a new indication of the drug. The review will see if the drug can be used as a treatment for adults with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have shown progression in other therapies. If successful this will expand the patient population the drug can be used in.

Glofitamab – a CD20xCD3 T-cell engaging bispecific antibody showed promising results from a Phase I/II study where it was used to treat those with large B-cell lymphoma, the most aggressive type if non-Hodgkin’s lymphoma. A complete response was seen in 40% of participants. The FDA has accepted the drug, from Genentech, for priority review in 2023.

Further References 

- Drugs to Watch 2023 - Coming soon - Clarivate
- Novel Drug Approvals for 2022 | FDA 
- What's new | European Medicines Agency (europa.eu)
- Key Potential Drug Launches 2022 | Pharma Intelligence (informa.com)