New Drug Approval Update: Therapies Pharmacies Should Know

Drug Topics JournalDrug Topics April 2021
Volume 165
Issue 4

Get the latest information on new treatments approved and marketed in the last year.

new drug approval

In a virtual presentation during the American Pharmacists Association 2021 Annual Meeting and Exposition, which was held March 12-15, Daniel Hussar, PhD, MS, dean emeritus and Remington Professor Emeritus of Pharmacy, Philadelphia College of Pharmacy, University of the Sciences, discussed newly available drugs for indications related to cardiovascular disease, insomnia, migraine, and COVID-19, among others. Hussar used a New Drug Comparison Rating (NDCR) system to evaluate the safety, efficacy, and administration value of the list of new drugs. The NDCR is as follows:

5 = important advance

4 = significant advantage(s)

3 = no or minor advantage(s) or disadvantage(s)

2 = significant disadvantage(s)

1 = important disadvantage(s)

According to Hussar, he intentionally centered his presentation around the drugs for which pharmacists are most likely to receive prescriptions, medication orders, or questions from patients.

Bempedoic Acid for Hypercholesterolemia

The first drug that Hussar presented was bempedoic acid (Nexletol; Esperion) for the treatment of hypercholesterolemia. The significance of the new drug indication is clear, according to Hussar. “Heart disease is the leading cause of death in the United States,” he said. “[Heart disease causes] an estimated 650,000 deaths each year. That’s higher than cancer-related deaths over the last year, it’s higher than the COVID-19–related deaths…and higher than the number of deaths occurring each year as a result of smoking-related complications.”

Bempedoic acid is an adenosine triphosphate-citrate lyase inhibitor that is administered orally as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established cardiovascular disease in patients who require additional lowering of low-density lipoprotein cholesterol (LDL-C). The first step in treating hypercholesterolemia is dietary modification. If this strategy fails, the most preferred treatment is a statin, according to Hussar. “So, as we look at the indication, bempedoic acid is indicated as an adjunct, [which] means we’re adding it to diet and maximally tolerated statin therapy,” Hussar said.

Hussar cited clinical trials reporting that adjunct treatment with bempedoic acid led to the additional lowering of LDL-C by approximately 18%. “When we can add that to the benefit of the statin, that’s all the better,” Hussar said.

Advantages of bempedoic acid include the following:

  • its unique mechanism of action;
  • its ability to extend the LDL-C–lowering effect of the statins;
  • the low risk for it to cause skeletal muscle adverse events (AEs), such as myopathy; and
  • its low propensity for reacting with other drugs.

The following are the disadvantages of bempedoic acid:

  1. It’s not a first-line treatment for lowering LDL concentrations.
  2. The effect of cardiovascular morbidity and mortality remains unknown.
  3. The drug may cause hyperuricemia and gout, and tendon rupture.
  4. It has not been evaluated in pediatric patients.

Based on the NDCR rating system, Hussar rated bempedoic acid at a 4, pointing to significant advantages, including that it is a good option for patients who do not tolerate statins well.

Lemborexant for Insomnia

Lemborexant (Dayvigo; Eisai) is an orexin receptor antagonist indicated to be administered orally for the treatment of insomnia in adults. “Lemborexant may have a familiar ring for you because this is the second drug that is classified as an orexin receptor antagonist, joining suvorexant, which was initially approved and marketed about 7 years ago, under the brand name Belsomra,” Hussar said.

There are various patterns of insomnia, Hussar explained. Patterns associated with sleep onset describe patients who have difficulty falling asleep, whereas sleep maintenance issues occur when patients have a hard time staying asleep. In the case of lemborexant, data showed that the new agent has both fast onset and long duration of action.

In a clinical trial, lemborexant was more effective than zolpidem extended release 6.25 mg. “I like comparisons like that, when companies are willing to do that,” Hussar said. “But keep in mind that a 6.25-mg dose of zolpidem extended release is a low dose, and a lot of individuals are on the 12.5-mg potency.”

However, lemborexant has not been compared with suvorexant. “I identify that as a disadvantage, when studies against the comparable agents could have been conducted but were not,” Hussar said. For this reason, lemborexant received a rating of 3, because the drug does not have any important advantages or disadvantages when compared with its predecessor, suvorexant, according to Hussar.

Lumateperone for Schizophrenia

Lumateperone tosylate (Caplyta; Intra-Cellular Therapies) is indicated to be administered orally for the treatment of schizophrenia in adults. The drug is similar to other orally administered atypical antipsychotic agents, including risperidone. “Most of the antipsychotic drugs have actions; typically, it’s a combined effect on certain serotonin receptor subtypes and certain dopamine receptors,” Hussar said.

Compared with risperidone, lumateperone may be less likely to cause extrapyramidal symptoms, weight gain, and hyperprolactinemia. As for its downsides, lumateperone may be less effective. Additionally, clinical response is less predictable with lumateperone, and the drug is only offered in 1 potency. “Think of some of the other antipsychotic drugs available in multiple potencies, actually a rather wide range of potencies,” Hussar explained.

“But…it is true that some individuals who either don’t experience the efficacy but do experience AEs with one of these agents, they may respond much better to the use of another agent. So, some would say that any new antipsychotic drug is welcomed as an option,” Hussar continued. Regardless, Hussar gave lumateperone a rating of 2, citing its unpredictability in response.

Ozanimod for Multiple Sclerosis

Indicated for the treatment of multiple sclerosis (MS), ozanimod (Zeposia; Celgene) is a sphingosine 1-phosphate (S1P) receptor modulator administered orally. There are a few different subtypes of S1P receptors. “Whereas the first of these agents, fingolimod, exhibits activity at 4 of the 5 known receptor subtypes of S1P, the newest agent has a more selective action in acting at S1P receptor subtypes 1 and 5,” Hussar said. In effect, ozanimod is less likely to cause cardiovascular AEs than other MS treatments.

Not only that, but treatment with ozanimod also doesn’t require CYP2C9 genotype testing, unlike some of the other drugs indicated for MS. Ozanimod is administered for relapsing forms of MS, which represents approximately 85% of patients, Hussar said.

One disadvantage of ozanimod is its potential to interact with a wider range of other drugs. Additionally, as an immunomodulator drug, ozanimod must be monitored for the possible increased risk of infection, according to Hussar. “I’ve given this drug a rating of 4—more advantages than disadvantages,” Hussar said.

Lasmiditan Hemisuccinate for Migraine

“The condition for which more new drugs were approved and marketed during 2020 than any other is migraine headache,” Hussar presented. An estimated 37 million Americans suffer from migraines in a range of severities and they are often debilitating, he said. Lasmiditan (Reyvow; Eli Lilly and Company) is a serotonin 1F receptor agonist approved for the treatment of adult patients with acute migraine with or without aura.

Hussar noted the several advantages of lasmiditan:

  1. It has a more selective action and has not been associated with vasoconstrictive effects.
  2. It is safer for use in a broader range of patients compared with similar drugs.
  3. It is less likely to lead to chest, throat, neck, or jaw pain or pressure, or lower seizure threshold.

However, lasmiditan has some drawbacks. It has not been directly compared with triptans in clinical studies. Other limitations are its higher likelihood to interact with heart rate-lowering drugs and to cause a central nervous system depressant action.

Lasmiditan received a rating of 4. “The message here is, yes, some individuals can benefit, but there are many others that don’t respond with the benefit that we would hope here when using these agents,” Hussar said.

Remdesivir for SARS-CoV-2

Lastly, Hussar spent time discussing remdesivir (Veklury; Gilead) for the treatment of COVID-19. Remdesivir is the first drug to be approved by the FDA for COVID-19 infection, according to Hussar. The drug is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, indicated for intravenous administration in adults and pediatric patients 12 years and older and weighing at least 40 kg who are hospitalized for COVID-19.

The largest clinical study for remdesivir set a primary end point of time to recovery, Hussar explained. “With the use of this drug, the median time to recovery was 10 days in comparison with a 15-day time to recovery when placebo was added to usual supportive care,” Hussar said.

Still, remdesivir has not yet demonstrated its ability to reduce the mortality rate in patients with COVID-19. Given the unprecedented situation, Hussar gave remdesivir a rating of 4. “It’s an important step forward. And my expectation is that we will see that the most effective [treatment] involves a combination of agents,” Hussar said.


  1. Hussar D. Your annual new drugs update. Presented at: American Pharmacists Association 2021 Annual Meeting and Exposition; March 12-15, 2021; virtual. Accessed March 15, 2021. 

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