Top Drug Approvals and Product Launches of 2020

Coronavirus disease 2019 (COVID-19) news may have dominated headlines for most of the year, but there were plenty of other noteworthy drug and product launches in 2020 that pharmacists were excited about.

New Drugs

As of late October 2020, First Databank (FDB) has added 75 new drug applications (NDAs), 223 abbreviated new drug applications (ANDAs), and 27 biologics license application (BLA) approval numbers to its MedKnowledge drug database. At press time, the FDA has approved 42 novel drugs, 62 first-time generics, and 45 medical devices in 2020.^1-3

Hussam Hamoush, PharmD, pharmacy manager and owner of Stonebriar Pharmacy in Frisco, Texas, called clascoterone (Winlevi; Cassiopea) cream 1% a huge breakthrough in acne treatment because it is the first medicine offering a nonantibiotic approach. The FDA approved clascoterone on August 27 and Cassiopea expects the drug to launch in early 2021.

“The [fewer] antibiotics that we use, the less chances [there are] of more drug-resistant bacteria,” Hamoush said. “This is a whole new approach in treating acne using a different mechanism of action. This will be huge for people that have had a lot of trouble with acne in the past.”

He also noted that rimegepant (Nurtec ODT; Biohaven Pharmaceuticals), which was approved on February 27, is a great drug for patients with migraine, as it only needs to be taken once to resolve migraine attacks in less than 1 hour.

“It’s a quick-dissolve tablet and with just 1 dose, it can prevent migraines for up to 48 hours,” Hamoush said.

In addition to rimegepant, lasmiditan (Reyvow; Eli Lilly and Company) and ubrogepant (Ubrelvy; Allergan
USA) have also been impactful for migraines this past year, as there have been no therapies with a novel mechanism of action for acute migraine treatment since triptans were first approved over 20 years ago. Julie Suko, PharmD, vice president of editorial content at FDB, noted that one of the most effective drugs in 2020 was naloxone, which, if administered quickly, can reverse opioid overdose effects within minutes.

“It’s available in several dose forms, but as a nasal spray can be used by untrained persons in case of accidental ingestion of opioids or suspected overdose,” she said.“While it’s not a new drug approval in 2020, the FDA announced new requirements in July to increase naloxone accessibility as an in-home antidote to tackle the opioid crisis head-on. Although different states have varying regulations, most allow naloxone to be furnished directly by the pharmacist, meaning that many more patients can gain access to this important and potentially life-saving treatment at the pharmacy counter when they are prescribed opioids.”

Another important new drug is peanut allergen powder-dnfp (Palfor- zia; Aimmune Therapeutics), which is used as oral immunotherapy to mitigate reactions, including anaphylaxis, caused by accidental peanut exposure in pediatric patients aged 4 to 17 years with confirmed peanut allergy. “This peanut allergen powder is the first drug to be approved in the United States for this indication,” Suko said. “Palforzia requires 3 phases of dosing––initial dosing, up-dosing, and maintenance––and therefore requires a commitment to frequent office visits.”

Another new drug is fostemsavir (Rukobia; ViiV Healthcare), an HIV-1 drug approved for use in combination with other antiretrovirals to treat adults with multidrug-resistant HIV-1 infection who are failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

“This oral extended-release tablet requires baseline and ongoing lab monitoring, including ongoing liver function testing,”Suko said. “It cannot be prescribed in patients with hepatitisBorC.”

Jamie Bearse, CEO and president of ZERO – The End of Prostate Cancer, noted that for the many men across the United States facing advanced prostate cancer, the approvals of olaparib (Lyn- parza; AstraZeneca Pharmaceuticals) and rucaparib (Rubraca; Clovis Oncology) signify resounding hope and new tools to help them fight for their lives.

“These drugs are the first [poly ADP-ribose polymerase (PARP)] inhibitors approved for use in prostate cancer, allowing prostate cancer to join the ranks of other cancers tied to the BRCA gene, such as breast and ovarian cancers, in being able to benefit from precision medicine,” he said.

According to Ryan Schmidt, PharmD, the associate director of formulary services at Navitus Health Solutions, in 2020 there was a trend of approvals primarily in the specialty space. Most of these products, particularly in the oncology segment, end up being clinically meaningful for the populations they target, but those are often quite small. However, the approval of elexacaftor/tezacaftor/ivacaftor and ivacaftor (Trikafta; Vertex Pharmaceuticals Incorporated) for cystic fibrosis (CF), albeit at the end of 2019, has had a major impact in 2020 for most patients with CF.

“In trials, it showed not only an improvement over existing treatment options, but also efficacy in patient populations for whom treatments had not been available,” Schmidt said. “This has led to a major shift in utilization. Approximately two-thirds of our patients using CFTR-modulating treatments have already switched to Trikafta.”

Another medication that aroused interest upon approval was bempedoic acid (Nexletol; Esperion Therapeutics), designed to lower low-density lipoprotein (LDL) cholesterol.

“As guidelines continue to push for lower goal levels of LDL to help prevent atherosclerotic cardiovascular disease, this potentially adds another option for treatment,” Schmidt said. “However, unlike products such as statins or PCSK-9 inhibitors, trial data regarding the impact of Nexletol on cardiovascular morbidity and mortality are not yet available. When [they are] available, we can expect a higher uptake in the use of this agent.”

Notable Product Launches

One of the areas that generated increased interest among health care providers in 2020 was digital therapeutics (DTx).

“DTx products deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease,” Suko said. “DTx products, typically reviewed or cleared by the FDA as software or as a medical device, are an important area to watch. Increasingly, DTx are being prescribed either to augment medication therapy or even as a companion therapy.”

Clinicians use these products in therapeutic areas such as behavioral health, as well as for chronic pain, attention deficit hyperactivity disorder, and heart failure.

DTx are a way to leverage technology to collect active and passive data in between face-to-face appointments. Monitoring takes place via patient-facing apps and sometimes remotely through wearables to evaluate how a patient is doing on a specific medication.

“That feedback can tell a clinician if they need to intervene or change a treatment plan, especially as it relates to changes that may need to be made to a medication or dosage to ensure therapeutically effective therapy,” Suko said. “DTx also can monitor if patients are adhering to their medications, so a clinician can contact the patient if there’s an issue so it can be corrected.”

In the targeted immunomodulatory space, 2 products approved last year— upadacitinib (Rinvoq; AbbVie) and risankizumab-rzaa (Skyrizi; AbbVie)— have had a big push in 2020.

“Although both of these products are joining existing classes, the marketing efforts are definitely noticeable in the uptake with these agents,” Schmidt said.“Another agent that is starting to pick up more utilization this year, which came out in late 2019, was Rybelsus (semaglutide), the first oral GLP-1 receptor agonist. This unique oral formulation provides an alternative for patients who may have trouble with or dislike injections, making it a very popular option for diabetes treatment.”

Looking Ahead

As the calendar turns to 2021, pharmacists envision another year full of important drug discoveries and innovative products.

“Fueled by the need for widespread influenza and eventually COVID-19 vaccinations, [there will be] more
and more pharmacists administering vaccines, educating people on vaccines and potential [adverse] effects, tracking vaccines via CVX and MVX codes, and much more,” Suko said. “We’ll also be watching for more biosimilar product approvals, which will increase competition and potentially offer cost savings to patients.”

Schmidt indicated that there are other areas on the horizon that should see some additional treatments over the next few years, although the pandemic has definitely created some questions around when approvals may actually happen.

“Although not new medications, ...SGLT2 inhibitors in heart failure could be significant and really expand product use from where it is today,” he said.“Interesting new approaches to HIV also lie ahead, including long-acting preventive medications and new mechanisms of action, which could lead to further advances in this space.