Mounjaro, Relyvrio, and More: 9 New Drugs Approved in 2022 That You Should Know About

Over the course of 2022, the FDA approved 37 novel (new) drugs. Many are firsts in their class — meaning they work differently than other drugs on the market. And many others help treat rare (orphan) diseases where options have been more limited.

Here we’ll cover what you should know about nine notable approvals from 2022, and what’s ahead for 2023.

1. Mounjaro

In May 2022, the FDA approved Mounjaro (tirzepatide), a once-weekly injection for adults with Type 2 diabetes. It’s the first dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist on the market.

Mounjaro works by mimicking gut hormones involved in blood glucose (sugar) control, digestion, and appetite. This is similar to another group of medications called GLP-1 agonists. But the way Mounjaro works is thought to have additive effects since it mimics an additional hormone.

During the SURPASS-1 trial, Mounjaro was shown to have positive effects on hemoglobin A1C (A1C) — your average blood glucose levels over 3 months. Over 40 weeks (a little over 9 months), people taking Mounjaro lowered their A1C by nearly 2% on average.

Mounjaro isn’t approved for weight loss, but people taking it tend to lose weight as a side effect. During the same trial, people lost between 15 lbs to 21 lbs of body weight with Mounjaro.

Note: Tirzepatide, the active ingredient, is currently being studied for chronic weight management in people with and without diabetes. Its manufacturer plans to apply for approval in 2023.

2. Quviviq

In January 2022, the FDA approved Quiviviq (daridorexant) for insomnia in adults. It works by blocking the effects of orexin — a chemical in your brain that’s involved in keeping you awake. Quviviq is available as an oral tablet that you take about 30 minutes before you go to bed.

Quviviq is an orexin receptor antagonist (ORA), and it’s not the first medication in its class. Other examples include Belsomra (suvorexant) and Dayvigo (lemborexant). All ORAs are considered controlled substances, meaning they have a risk of misuse and dependency.

A common side effect of ORAs is feeling drowsy the next day, especially if you aren’t planning to sleep for at least 7 hours. Quviviq also has this risk, but it’s thought to be less likely. That’s because compared to other ORAs, Quviviq lasts the shortest amount of time in your body.

3. Cibinqo

Cibinqo (abrocitinib) is another new medication that was approved in January 2022. It’s an oral Janus kinase (JAK) inhibitor approved to treat atopic dermatitis in adults. Other JAK inhibitors approved for this use include Rinvoq (upadacitinib) and Opzelura (ruxolitinib).

JAK inhibitors, like Cibinqo, work by blocking enzymes (proteins) called JAKs that are involved in inflammation. This action can help reduce itching and other symptoms of atopic dermatitis. Your healthcare provider may recommend a JAK inhibitor if other treatments haven’t worked for you.

The FDA approved Cibinqo and Rinvoq for atopic dermatitis on the same day, making them the first JAK inhibitors approved for this use. However, Rinvoq was approved for people ages 12 and up, while Cibinqo was only approved for adults. And while Cibinqo is new, Rinvoq has been on the market since 2019 for other uses.

4. Relyvrio

In September 2022, the FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) for amyotrophic lateral sclerosis (ALS) in adults. It comes as a packet of medication that you mix with water before taking by mouth or feeding tube.

Relyvrio won’t cure ALS, but it’s the first treatment that may slow down the progression of the disease and extend survival. Experts don’t know exactly how it works.

An FDA expert panel initially voted against approving Relyvrio. That’s because the only evidence available was from a small clinical trial. But ALS advocates, including experts and people living with the condition, petitioned the FDA for the medication’s approval.

A larger clinical trial is currently underway, which is set to wrap up in 2024. The manufacturer has said that if the findings aren’t positive, the medication will be pulled from the market. In the meantime, people living with ALS may have another option to try.

5. Daxxify

Daxxify (daxibotulinumtoxinA-lanm), a longer-lasting alternative to Botox for wrinkles, was approved in September 2022. At the time, it was only approved to lessen the appearance of frown lines. Since then it has also been approved for neck spasms in adults.

Daxxify works just like Botox — by temporarily blocking nerve signals to your muscles. But its results seem to last longer, meaning fewer injections throughout the year. However, Botox is also approved to lessen forehead lines and crow's feet, whereas Daxxify is not.

6. Vivjoa

In April 2022, the FDA approved Vivjoa (oteseconazole) for chronic yeast infections. While other medications are sometimes used off-label, Vivjoa is the first one approved for this use.

Vivjoa is an oral azole antifungal medication. It works by making the fungus’ cell wall (outer protective covering) weaker. This is similar to other azole antifungals, like fluconazole (Diflucan). And it appears to clear a yeast infection just as well as fluconazole, too.

There are two ways to take Vivjoa. When taken on its own, you’ll take Vivjoa for a total of 12 weeks. If you take it with fluconazole (Diflucan), your treatment regimen will last for 14 weeks.

Vivjoa can last for almost 2 years in your body after your last dose. And since Vivjoa can harm a fetus, this can be a problem if you’re able to get pregnant. Because of this, you should only take it if you can’t get pregnant.

7. Enjaymo

In February 2022, the FDA approved Enjaymo (sutimlimab-jome) for a rare type of anemia called cold agglutinin disease (CAD). CAD is a condition where your immune cells attack healthy red blood cells, leading to anemia. Blood transfusions are sometimes needed to replace these cells.

Enjaymo is the first medication approved for CAD. It’s given as an infusion into your vein by your healthcare provider. And unlike the other medications we’ve covered so far, it’s a biologic that is made from living sources. Enjaymo works by preventing immune cells from destroying red blood cells, reducing the need for blood transfusions.

8. Camzyos

In April 2022, the FDA approved Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy (oHCM). This is a condition that makes it harder for your heart to fill with blood and pump it out due to thickening of the heart walls.

As a cardiac myosin inhibitor, Camzyos is the first and only medication in its class. It also targets the underlying cause of oHCM, unlike other treatment options. Camzyos works by helping the heart relax, allowing it to fill with enough blood.

Camzyos is only available through a special risk management program. In this case, your healthcare provider needs to be certified to prescribe it. And you’ll only be able to receive it through certified pharmacies. You also need to enroll in the program.

9. Sunlenca

Sunlenca (lenacapavir) was approved in December 2022 for treatment of HIV. It’s the first of a new class of antiviral medications called capsid inhibitors. Sunlenca works by interfering with the virus’ shell, preventing HIV from making copies of itself.

Sunlenca is available as a tablet, and as an injection that you give under the skin. After completing your starting dose (which includes tablets with or without an injection), you’ll receive Sunlenca injections every 6 months.

You’ll typically take Sunlenca in combination with other HIV medications. It may be added to your regimen if other treatments haven’t worked or aren’t safe for you.

Other 2022 new drug approvals

In addition to those covered above, examples of other new drugs approved in 2022 include:

• Briumvi (ublituximab-xiiy): A first-in-class monoclonal antibody for relapsing multiple sclerosis

• Sotyktu (deucravacitinib):A first-in-class oral medication for plaque psoriasis in adults

• Tzield (teplizumab-mzwv): A first-and-only treatment for delaying the onset of Stage 3 Type 1 diabetes

• Vtama (tapinarof):A first-in-class steroid-free topical medication for plaque psoriasis in adults

New drug approvals anticipated in 2023

While many notable new drugs were approved in 2022, there are several anticipated over the course of 2023. In January 2023, Leqembi (lecanemab) was approved for Alzheimer’s disease. A few others that may follow include:

• Zuranolone: An oral medication given as a 14-day treatment course for major depressive disorder and postpartum depression 

• Sotatercept: A first-in-class medication for pulmonary arterial hypertension

• Mirikizumab: A first-in-class medication for Crohn’s disease and ulcerative colitis

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Written by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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