Top 3 new drug approvals

The top 3 new US drug approvals include the first non-opioid treatment for opioid withdrawal, a migraine prevention drug, and the first biosimilar for anemia. Here are the top 3 new drugs, approved within the last week.

• Lofexidine hydrochloride (Lucemyra. US WorldMeds) is the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms.

“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA. “The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments.”

Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD, according to FDA.

FDA is requiring 15 postmarketing studies on the drug, including both animal and human studies. Additional animal safety studies will be required to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children.

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   2.   Everenumab-aooe (Aimovig, Amgen) is the first preventive treatment of migraine headaches in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

The treatment is given by once-monthly self-injections.

“Aimovig provides patients with a novel option for reducing the number of days with migraine,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA. “We need new treatments for this painful and often debilitating condition.”

The effectiveness of Aimovig for the preventive treatment of migraine was evaluated in 3 clinical trials. In one study with 955 participants who had a history of episodic migraine, Aimovig-treated patients experienced, on average, 1 to 2 fewer monthly migraine days than those on placebo.

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   3.    Epoetin alfa-epbx (Retacrit, Hospira/ Pfizer), a biosimilar to epoetin alfa (Epogen/Procrit), is the first FDA-approved biosimilar to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

“Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs,” said Leah Christl, PhD, director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research, in an FDA statement.

FDA’s approval of Retacrit is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Retacrit is biosimilar to Epogen/Procrit.

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