Meeting News

3 recent FDA approvals PCPs need to know

Gerald Smetana 2018
Gerald Smetana

PHILADELPHIA — Within the past year, the FDA has approved three important new drugs for the treatment of common conditions that internists should be aware of, according to a presentation at the ACP Internal Medicine Meeting.

“This year is actually one of the most exciting years for potential new drugs for primary care,” Gerald Smetana, MD, professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, said during his presentation.

Baloxavir marboxil (Xofluza, Genentech)

Baloxavir marboxil, a novel antiviral, was approved by the FDA in October 2018 for the treatment of influenza, Smetana said.

Influenza is common in the United States, with about 10 to 30 million cases per year depending on the season, and contributes to a number of hospitalizations, medical visits and deaths, he said.

Data have shown that a single dose of baloxavir is as effective as 5 days of the existing treatment oseltamivir for symptom resolution and is very well tolerated, he said. The drug is effective for some oseltamivir-resistant strains, he said.

Baloxavir has only been studied in patients with symptoms lasting less than 48 hours, Smetana noted. Synergy with other medications, such as neuraminidase inhibitors, has been observed, he said.

The medication is expensive, but it is similar to other new drugs that come to market, he said.

“Baloxavir is an important addition for us to know about and has an important role to play in next year’s flu season,” Smetana said.

Solriamfetol (Sunosi, Jazz Pharmaceuticals)

Solriamfetol, a novel reuptake inhibitor, was approved just last month by the FDA for the treatment of excessive daytime sleepiness, he said.

“Rates of sleep apnea are substantial in the United States unfortunately and are paralleling the obesity epidemic,” Smetana said.

Solriamfetol is slightly more effective than existing treatment modafinil for excessive sleepiness in patients with obstructive sleep apnea despite therapy with continuous positive airway pressure, he said.

Research showed that adverse events, including headaches, anxiety, anorexia and insomnia, were common in patients treated with solriamfetol, he said. These side effects were dose-related to the highest dose (300 mg), he said. The drug is approved at a dose of 150 mg or less, he said.

“The cost of solriamfetol is not known yet, but if priced comparably to existing therapy, it will be a reasonable alternative that could potentially be a first line drug for this indication,” Smetana said.

Erenumab-aooe (Aimovig, Amgen)

Erenumab, a novel monoclonal antibody, was approved by the FDA in May 2018 for the treatment and prevention of migraine, he said.

Migraine is common, with a prevalence rate of about 10% to 12%, and is an important cause of disability, according to Smetana.

Data have shown that erenumab reduces migraine days by 50% and substantially improves quality of life, he said. The new medication is safe and well tolerated and can be administered at home via a single monthly injection, he said.

There is a potential CV risk with erenumab, he said. Longer term data are needed to establish that risk, Smetana said.

The cost of erenumab is comparable to Botulinum toxin and is easier to administer, he said.

“This new drug is a major advance for patients who are disabled by migraines and tolerate existing treatments poorly,” Smetana said.

“I think this class of medicine is going to be the first biologic to gain lifespan use in primary care,” he said. “For most of us who aren’t comfortable prescribing yet, this could be a game changer.” – by Alaina Tedesco

 

Reference:

Smetana G. New FDA-approved medications that you need to know about. Presented at: ACP Internal Medicine Annual Meeting. April 11-13, 2019; Philadelphia.

Disclosure: Smetana reports no relevant financial disclosures.

 

Gerald Smetana 2018
Gerald Smetana

PHILADELPHIA — Within the past year, the FDA has approved three important new drugs for the treatment of common conditions that internists should be aware of, according to a presentation at the ACP Internal Medicine Meeting.

“This year is actually one of the most exciting years for potential new drugs for primary care,” Gerald Smetana, MD, professor of medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, said during his presentation.

Baloxavir marboxil (Xofluza, Genentech)

Baloxavir marboxil, a novel antiviral, was approved by the FDA in October 2018 for the treatment of influenza, Smetana said.

Influenza is common in the United States, with about 10 to 30 million cases per year depending on the season, and contributes to a number of hospitalizations, medical visits and deaths, he said.

Data have shown that a single dose of baloxavir is as effective as 5 days of the existing treatment oseltamivir for symptom resolution and is very well tolerated, he said. The drug is effective for some oseltamivir-resistant strains, he said.

Baloxavir has only been studied in patients with symptoms lasting less than 48 hours, Smetana noted. Synergy with other medications, such as neuraminidase inhibitors, has been observed, he said.

The medication is expensive, but it is similar to other new drugs that come to market, he said.

“Baloxavir is an important addition for us to know about and has an important role to play in next year’s flu season,” Smetana said.

Solriamfetol (Sunosi, Jazz Pharmaceuticals)

Solriamfetol, a novel reuptake inhibitor, was approved just last month by the FDA for the treatment of excessive daytime sleepiness, he said.

“Rates of sleep apnea are substantial in the United States unfortunately and are paralleling the obesity epidemic,” Smetana said.

Solriamfetol is slightly more effective than existing treatment modafinil for excessive sleepiness in patients with obstructive sleep apnea despite therapy with continuous positive airway pressure, he said.

Research showed that adverse events, including headaches, anxiety, anorexia and insomnia, were common in patients treated with solriamfetol, he said. These side effects were dose-related to the highest dose (300 mg), he said. The drug is approved at a dose of 150 mg or less, he said.

“The cost of solriamfetol is not known yet, but if priced comparably to existing therapy, it will be a reasonable alternative that could potentially be a first line drug for this indication,” Smetana said.

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Erenumab-aooe (Aimovig, Amgen)

Erenumab, a novel monoclonal antibody, was approved by the FDA in May 2018 for the treatment and prevention of migraine, he said.

Migraine is common, with a prevalence rate of about 10% to 12%, and is an important cause of disability, according to Smetana.

Data have shown that erenumab reduces migraine days by 50% and substantially improves quality of life, he said. The new medication is safe and well tolerated and can be administered at home via a single monthly injection, he said.

There is a potential CV risk with erenumab, he said. Longer term data are needed to establish that risk, Smetana said.

The cost of erenumab is comparable to Botulinum toxin and is easier to administer, he said.

“This new drug is a major advance for patients who are disabled by migraines and tolerate existing treatments poorly,” Smetana said.

“I think this class of medicine is going to be the first biologic to gain lifespan use in primary care,” he said. “For most of us who aren’t comfortable prescribing yet, this could be a game changer.” – by Alaina Tedesco

 

Reference:

Smetana G. New FDA-approved medications that you need to know about. Presented at: ACP Internal Medicine Annual Meeting. April 11-13, 2019; Philadelphia.

Disclosure: Smetana reports no relevant financial disclosures.

 

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