Industry Watch I The 9 Most Influential Products approved by the FDA (Year 2023)
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As of December 27, 2023, the U.S. FDA's Center for Drug Evaluation and Research (CDER) has approved 56 new therapies. That's an increase of about 51 percent from the 37 drugs approved by CDER in 2022, which was the lowest number of new drugs approved by the center in any year since 2016.



The FDA approves hundreds of new drugs every year. Some of these are first-in-class drugs for mechanism targets, while others are introducing new subdivided drugs/therapies in areas with known mature mechanism targets. However, more generic drugs or biosimilar drugs are used to promote the reduction of social medical burden. Each new drug deserves attention, but because of the differences in the expected impact of drugs, here we'll review the nine most influential drugs/vaccines approved by the FDA in 2023. In particular, this is not an exhaustive list and only reflects products approved before December 27 of the year.

01 Paxlovid is used for the treatment of COVID-19
Paxlovid (Nematovir/Ritonavir) is an antiviral drug for mild to moderate COVID-19 patients who are at high risk of severe illness. It was originally authorized for emergency use in late 2021. After more than 11 million courses of use worldwide, it was officially approved by the FDA in May 2023. The National Institutes of Health (NIH) recommends Paxlovid as the preferred treatment for non-hospitalized adults and adolescents 12 years and older, where it is preferred over its peers such as Veklury (Redesivir) and Lagevrio (Monolavir).

02 Respiratory syncytial virus vaccine
Respiratory syncytial virus (RSV) usually causes the symptoms of the common cold. But for some people - especially infants and the elderly - RSV can be particularly dangerous. Prevention before RSV complications occur is ideal. In 2023, the FDA approved three new products that could prevent illness caused by this respiratory virus. Previously, the only RSV prevention option was the drug Synagis (Palizumab) for certain infants.
Arexvy (RSVPreF3, GSK) : This is the first RSV vaccine approved by the FDA. Adults age 60 and older can get one dose before RSV season.
Abrysvo (RSVpreF, Pfizer) : This RSV vaccine was approved a few months after Arexvy. Adults age 60 and older and certain pregnant women can get a dose before RSV season.
Beyfortus (nirsevimab, Sanofi) : This monoclonal antibody vaccine reduces the risk of RSV-related hospitalizations and visits. It is recommended for all infants under 8 months and some children under 19 months.

03 OTC Contraceptive
Opill (onorgestrel) is the first OTC contraceptive in the United States. It was approved by the FDA in July 2023 and is scheduled to be available in early 2024. Consumers can buy this progestogen-only drug through pharmacies, large retailers, online stores and other places. What makes Opil unique is its convenience. Many Americans struggle to get prescription birth control pills. In fact, one US study found that as many as 33% of women experience obstacles when trying birth control, and Opil has the ability to significantly meet this need.

04 Zurzuvae for postpartum depression
Up to 20 percent of American women experience postpartum depression (PPD), which is a period of significant depression shortly after giving birth. If left untreated, it can cause long-term harm to the child and mother. Zurzuvae (Zuranolone) is a significant advance in the treatment of PPD. This fast-acting antidepressant was approved by the FDA in August 2023. It can begin to significantly improve PPD symptoms in as little as 3 days. In contrast, traditional antidepressants can take weeks to work. Injectable PPD drugs require more than 60 hours of intravenous administration in a formal health care facility, which is a challenge for many patients. When it comes to postpartum depression, Zurzuvae will revolutionize the market landscape in this treatment area.

05 Leqembi for Alzheimer's disease
Most Alzheimer's drugs can have a positive effect on thinking, judgment and memory. But they don't necessarily address the underlying cause of the condition. Leqembi (Lencanetzumab) is a new development in the treatment of Alzheimer's disease. It is the first clinically supported Alzheimer's drug that targets the underlying cause of the disease. Leqembi reduced the severity of dementia symptoms by an average of 27 percent over a 1.5 year period, compared with placebo (without any drug injections). Such data led to Leqembi's full FDA approval in July 2023. By slowing the progression of Alzheimer's disease in its early stages, people may have more time to participate more fully in daily life and live independently. This means a person has more time to drive safely, handle family finances accurately, and engage in hobbies and interests.

06 Over-the-counter naloxone for the treatment of opioid overdose
Naloxone is so effective in combating opioid abuse that it can reverse opioid overdoses and save lives. Naloxone was previously only available through pharmacists or health care providers, which was a barrier for many. Now, with the FDA approving the first over-the-counter naloxone product, it has become even more accessible. Two naloxone nasal sprays were approved in March 2023 (NARCAN) and July 2023 (RiVive). People now see it as an over-the-counter product, just like ibuprofen or cough drops or any other product they can buy, and that really helps to take the fear out of the opioid addiction community and make it more accessible to them to reverse opioids for crisis situations.

07 Zepbound for long-term weight management
Zepbound (Tizepatide) is a new long-term option for weight control that can help patients eat less and feel fuller longer with just one injection per week. It has the same active ingredient as Mounjaro, a type 2 diabetes treatment. Zepbound's effectiveness makes it stand out. In clinical studies, it helped people lose an average of 34 to 48 pounds after 72 weeks (16.5 months). About a third of the subjects who took the higher dose lost 25 percent of their body weight. Zepbound stood out from its class not only because of its weight loss but also because of its high tolerance in patients, with patients treated with Zepbound reporting that they felt 'at ease' when it came to eating and no longer feeling trapped in a cycle of calorie loss, increased hunger and weight regain. Zepbound isn't for everyone, though. It is approved for adults who are considered obese (BMI of 30 or higher). It is also approved for adults who are considered overweight (BMI 27 or higher) and have other weight-related health conditions, such as type 2 diabetes, high blood pressure, or high cholesterol.

08 Roctavian for hemophilia A
Roctavian (valoctocogene roxaparvovec) is the first gene therapy for adults with severe hemophilia A, an inherited bleeding disorder. Severe hemophilia A can cause uncontrolled long-term bleeding, and reducing the frequency and severity of these bleeds is a top priority for everyone living with this condition. A one-time dose can reduce the number of times a person bleeds by more than 50 percent per year, and it can also significantly reduce the need for other maintenance medications. Despite being called the most expensive drug in history (about 14.48 million yuan per pill), some analyses suggest that Roctavian is more cost-effective than rival drugs such as Hemlibra (Emesezumab).

09 Casgevy and Lyfgenia gene therapies for sickle cell disease
Sickle cell disease (SCD) is an inherited blood disorder. It is a painful and expensive disease that often requires frequent blood transfusions and daily maintenance medications. In December 2023, the FDA approved the first two SCD gene therapies. They are designed as a single dose infusion to help adults with SCD and children 12 years and older avoid pain crises and health complications over time. Casgevy - also known as exagamglogene autotemcel (or simply "exa-cel"). In addition to its potential therapeutic benefits for SCD, its mechanism of action is also noteworthy. Casgevy is the first FDA-approved drug to use CRISPR-Cas9 gene-editing technology. This innovative drug can target the shutdown of the inherited gene that causes SCD. Lyfgenia is another gene therapy approved by the FDA. This new, promising gene therapy, which uses more traditional gene-editing techniques to help eliminate pain crises, is expected to be available in early 2024.

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