Breifs

FDA Approves First Ebola Vaccine

The FDA approved Merck’s Ervebo Ebola vaccine, the first vaccine given the go-ahead for protection against the deadly virus in patients 18 and older.

Ervebo only protects against the Zaire ebolavirus strain and the effectiveness and duration of protection is not currently known.

Merck anticipates that the vaccine will be available in the third quarter of 2020. The company is working with the WHO, UNICEF, the U.S. and Gavi, an international vaccine alliance, to create a plan for public health preparedness and response efforts.

Daiichi Sankyo’s Enhertu Gets Accelerated Approval for Breast Cancer

Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) has received the FDA’s accelerated approval status for treating adults with HER2-positive breast cancer.

The agency approved the drug for patients with unresectable or metastatic HER2-positive breast cancer who have already received two or more anti-HER2-based regimens.

The approval stemmed from a clinical trial of 184 female patients, 60.3 percent of which experienced some tumor shrinkage.

TGA Fines Mundipharma Over Opioid Advertisement

U.K.-based drugmaker Mundipharma was fined by Australia’s Therapeutic Goods Administration for a misleading claim in its oxycodone advertising.

The agency fined the drugmaker Aus$302,400 ($208, 610) over a claim in its promotional material for Targin (oxycodone). The advertisement, which was directed at healthcare professionals, encouraged the use of opioids in multimodal pain management plans.

“Opioids should not be represented as a core component of the multimodal management of chronic non-cancer pain, and the decision to prescribe opioids should be approached with significant caution,” TGA said.

FDA Approves First Anticoagulant Generics

The FDA approved the first two generic tablets of Bristol-Myers Squibb’s blood thinner Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a type of irregular heart rhythm.

The approvals granted to Micro Labs and Mylan mark the first time the agency has given its go-ahead for a direct oral anticoagulant generic.

Apixaban increases the risk of thrombotic events and strokes if a patient stops taking the medication too soon, the FDA said. The drug can cause epidural or spinal hematomas in patients who are also receiving neuraxial anesthesia or are undergoing a spinal puncture, the agency warned.

FDA Approves First-of-its-Kind Migraine Treatment

Allergan’s Ubrelvy (ubrogepant) tablets received the FDA’s approval for the immediate treatment of migraine with or without aura, a visual disturbance or sensory phenomenon caused by the condition.

The novel drug, which is not indicated for preventive treatment, is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists the FDA has approved for acute migraine treatment.

The drug “represents an important new option for the acute treatment of migraine,” according to Billy Dunn, acting director of CDER’s Office of Neuroscience, who noted that that approximately 37 million people in the U.S. experience migraines.

Eisai’s Dayvigo Earns FDA Approval for Insomnia

The FDA granted approval to Eisai’s Dayvigo (lemborexant) 5mg and 10mg for the treatment of insomnia in adults.

The approval was based on positive results from two phase 3 studies of Dayvigo versus placebo for up to one month, followed by six months.

As part of the approval, the agency recommended to the Drug Enforcement Administration that the drug be classified as a controlled substance.

Astellas and Seattle Genetics’ Padcev Gets Accelerated Approval for Urothelial Cancer

The FDA granted accelerated approval to Astellas and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.

Padcev was approved based on the results of a clinical trial of 125 patients who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, of which 44 percent had some tumor shrinkage.

The agency previously granted Padcev priority review and breakthrough therapy designations. As a condition of its accelerated approval, a further clinical trial is required to verify and describe it’s clinical benefit.