Significant drug approvals in 2022 and predictions for 2023

Following numerous tumultuous years, the Biopharma industry saw a steady therapeutic growth in 2022 with various breakthrough drugs hitting the market - setting the industry up for an exciting 2023.

With the US Food and Drugs Administration (FDA) approving 37 novel drugs, the medical prospect for patients globally is looking promising. However, this statistic is much lower compared to previous years, with 50 approvals in 2021, 53 in 2020, 48 in 2019 and a record-breaking 59 approvals in 2018.?

With those statistics in mind, there’s no denying that 2022 felt like a relatively slow year for the agency’s drug approvals. Despite this, these figures do still represent a steady process, and definitely do not indicate a decline for the industry.

So, what were the most groundbreaking FDA drug approvals of 2022, and what can we expect from the market in 2023.

A recap of 2022's FDA drug approvals:

As previously mentioned, the number of FDA drug approvals in 2022 was significantly lower than previous years, but reasons for the drop-off have not been made strikingly obvious - though there are a few possibilities.?

Speculative reasons for this decline include the lingering impact of the pandemic, which produced an approval backlog that required masses of regulatory documents to sift through, paired with staff shortages. On another note, drug approvals may have slowed due to the FDA being more cautious with their novel drug applications, after an accelerated approval for a novel Alzheimer’s therapy in June garnering criticism.

Throughout 2022, the majority of new FDA drug approvals had a focus on oncology, infectious diseases, autoimmune/ inflammatory diseases and neurological conditions. Numerically, oncology drugs were the frontrunners for 2022 with 11 new approvals, with autoimmune therapies following closely behind at 7 new drugs hitting the market.?

A few examples of the indications these novel drugs are targeting are as follows:

• Oncology: Lung cancer, prostate cancer, breast cancer and a rare overgrowth syndrome known as PROS
• Autoimmune and inflammatory conditions: Inflammatory bowel disease, lupus nephritis and arthritis?
• Infectious diseases: COVID-19, influenza, HIV and smallpox
• Neurological conditions: Spinal muscular atrophy and amyotrophic lateral sclerosis

Rare disease drug approvals of 2022:

Though 2022 seemed like a slower year, it proved prosperous for rare disease drug approvals. Out of the 37 drugs, 20 (or 54%) of those were novel drug approvals for rare diseases, helping to fulfil the unmet needs of patients across the entire globe.

Rare disease and orphan drugs are at the crux of pioneering, ground-breaking medical advancements, and a couple of this year’s approvals include:

• Amvuttra: Utilised for the treatment of polyneuropathy in adults (damage of multiple nerves throughout the body), Amvuttrra is supplied via an injection.
• Kimmtrak: The first and only FDA-approved drug of its kind, Kimmtrack was developed to treat uveal melanoma, a rare type of eye cancer.??
• Xenpozyme: An enzyme-replacement therapy, Xenpozyme was developed for patients with acid sphingomyelinase, a progressive and incredibly rare genetic disease.

First-in-class drug approvals of 2022

Overall, out of the 37 drugs approved, 27 of these were first-in-class therapies. To clarify, first-in-class drugs operate via a novel, unique mechanism of action, offering a new therapeutic approach to treating the disease in question.?

Though first-in-class therapies are not classed as a regulatory status, the FDA do often place these drugs under favourable designations to fast-track these treatments into the approval stages - streamlining the review process as a result.?

Here’s just a few from the extensive list of first-in-class drugs that were approved last year:

• Camzyos: Developed for patients living with a specific type of symptomatic obstructive hypertrophic cardiomyopathy, to improve the heart’s overall functional capacity and lessen the symptoms for those suffering.?
• Mounjaro: Also known as Tirzepatide, Mounjaro was granted fast designation as a treatment for adults with type II diabetes. Utilised in conjunction with a healthy diet and exercise, the weekly injection works to control the body’s blood sugar levels.
• Pluvicto: Used to treat adults living with prostate-specific, membrane-positive, metastatic, castration-resistant prostate cancer, who have been treated with two therapies previously, the Pluvicto injection was approved at the start of 2022.

Accelerated approvals of 2022

Back in 1992, the FDA developed an Accelerated Approval scheme, allowing chosen drugs to be fast-tracked through the approval process. The idea behind this strategy was to help life-altering medications that offer a meaningful advantage over currently available treatments hit the shelves faster, fulfilling significant gaps in the medical market.

Out of the 37 drugs approved last year, 6 of these (16%) were under Accelerated Approval. A few of 2022’s accelerated approval drugs were as follows:

• Elahere: A treatment developed for patients living with recurring ovarian cancer that’s resistant to platinum therapy.
• Lunsumio: A cancer medication for treating adults with relapsed or refractory follicular lymphoma.
• Tecvayli: Developed to treat adult patients suffering with relapsed or refractory multiple myeloma who have received at least four specific prior therapies.
• Vonjo: Used to treat adults with primary or secondary myelofibrosis in adults with low platelets, at intermediate or high-risk.

Cause for optimism in 2023

After a steady year in 2022, it looks like 2023 is set to be an exciting year of innovation and advancement, with a predictive analysis highlighting several blockbuster drugs reaching clinical trials by 2027. According to the annual ‘Drugs to Watch 2023 ’ report issued by Clarivate, 2023 new product launches are set to focus on immunological and inflammatory diseases.?

Out of the 70 potential drugs highlighted in the report, a large proportion were revealed to be personalised medicines. Personalised medicine is an advancing field, allowing patient needs to be met to an even higher standard utilising emerging innovations to ensure patients get the best treatment for their exact needs.

Drugs to Watch

The report details an extensive selection of new medical advancements that may make an appearance throughout the year. Below are a few therapies that are set to make waves in 2023:

• Lecanemab: Exciting news to kick off the year, as accelerated approval was granted for Lecanemab, a monoclonal antibody developed by Eisai Co Ltd and Biogen Inc . One of the very first experimental drugs to slow the progression of Alzheimer’s disease and cognitive deterioration, this marks a serious innovation in this area of medicine. However, the innovation has not been without controversy, with many commentators questioning the drug’s risk to patient safety .
• Foscarbidopa: Parkinson’s disease sadly impacts around 6,000,000 people worldwide, highlighting the increasing demand for treatment to serve these unmet needs. Developed by AbbVie , Foscarbidopa is a novel reformulation therapy of an original treatment that is delivered via a subcutaneous pump. The goal of the treatment is to improve motor fluctuations that come as a symptom of the advanced stages of the deteriorative disease.?
• Capivasertib: AstraZeneca , in collaboration with Astex Pharmaceuticals , have seen exciting developments to their investigational Capivasertib drug, which will be a big one to watch during 2023. Currently in Phase III trials, the potential first-in-class treatment is a pan-AKT kinase inhibitor for multiple subtypes of breast and prostate cancer, driven by a growing understanding of breast cancer biology and treatments.

This is just a small insight into what’s to come in 2023, so make sure to check out Clarivate’s full report for a deeper look into what treatments to expect on the market throughout the year.?

Overall, these drugs are set to meet vast unmet medical needs globally, which will mark a transformative year in the Pharmaceutical industry.?