FDA News - July 2016

VBCN - July 2016 Volume 3, No 2

In This Article




Zinbryta a New Treatment Available for Relapsing Multiple Sclerosis

On May 27, 2016, the FDA approved daclizumab (Zinbryta; Biogen/AbbVie), a long-acting injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab can be self-administered by the patient. Daclizumab is recommended for patients who had an inadequate response to ≥2 drugs for MS, because of its safety profile.

Daclizumab was approved for relapsing MS based on 2 double-blind, controlled clinical trials that used 150 mg of daclizumab, administered once monthly. The first trial compared daclizumab with interferon beta-1a (Avonex) in 1841 patients with relapsing MS. The daclizumab group had a 45% relapse reduction and a 54% reduction in new or enlarging T2 hyperintense lesions versus the interferon beta-1a group. The second study compared daclizumab with placebo in 412 patients with relapsing MS. Daclizumab had a 54% relapse reduction, a 57% reduction in disease progression, a 70% reduction in new or newly enlarging T2 hyperintense lesions, and a 69% reduction in new T1 Gd-enhancing lesions versus interferon beta-1a. Of note, 81% of patients using daclizumab were relapse-free compared with 64% in the interferon beta-1a group.

The most common adverse events reported with daclizumab in the 2 studies included nasopharyngitis, upper respiratory tract infection, eczema, rash, influenza, dermatitis, depression, oropharyngeal pain, lymphadenopathy, and increased alanine aminotransferase levels.

Daclizumab was approved with a boxed warning about the serious risk for hepatic injury, including autoimmune hepatitis and other immune-mediated disorders. Transaminase and bilirubin levels should be evaluated before starting daclizumab therapy, and patients should be monitored monthly and up to 6 months after stopping therapy. Dac­lizumab is distributed through a Risk Evaluation and Mitigation Strategies program only.

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Nuplazid First Drug Approved for Hallucinations and Delusions Associated with Parkinson's Disease

On April 29, 2016, the FDA approved pimavanserin (Nuplazid; Acadia), an atypical antipsychotic, for the treatment of hallucinations and delusions associated with Parkinson's disease. Pimavanserin is the first drug approved by the FDA for hallucinations and delusions that are associated with Parkinson's disease.

“Hallucinations and delusions can be profoundly disturbing and disabling. Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms,” said Mitchell Mathis, MD, Director of the FDA's Division of Psychiatry Products.

As many as 50% of patients with Parkinson's disease experience hallucinations and delusions; these serious symptoms can add to the burden of physical limitations in patients with this disease.

Pimavanserin was approved under the FDA's priority review status and was earlier granted a breakthrough therapy designation in an effort to expedite the development and approval process. Although its mechanism of action is still not fully understood, the effect of pimavanserin may be mediated through a combination of inverse agonist and antagonist activity at serotonin 2A receptor (5-HT2A) and, to a lesser extent, at serotonin 5-HT2C receptors.

The efficacy of pimavanserin was established in a randomized, placebo-­controlled, parallel-group, 6-week clinical trial involving 199 patients with Parkinson's disease who experienced hallucinations and/or delusions. Patients receiving pimavanserin had less frequent and/or less severe hallucinations and delusions, without worsening the primary motor symptoms of Parkinson's disease, compared with those receiving placebo.

The most common adverse effects associated with pimavanserin were peripheral edema and a confused state. Pimavanserin was approved with a boxed warning cautioning healthcare professionals about the risk for death in elderly patients with dementia-related psychosis who use antipsychotic drugs. Pimavanserin is not approved for the treatment of patients with dementia-related psychosis that is unrelated to hallucinations and delusions associated with Parkinson's disease psychosis.

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