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Regulatory Focus™ > News Articles > 2020 > 5 > New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

Posted 27 May 2020 | By Renee Matthews 

New approvals and indication from FDA: Alunbrig, VESIcare LC, Kynmobi and more

This is the first in a series of weekly roundups of new drug approvals and indications from the US Food and Drug Administration (FDA).
Alunbrig gets new indication as first-line therapy for ALK-positive metastatic NSCLC

On 22 May, FDA approved a new indication for Takeda’s Alunbrig (brigatinib) as a first-line treatment for adults with anaplastic lymphoma kinase‒positive metastatic non‒small cell lung cancer (NSCLC). The agency also approved a companion diagnostic, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit.
Alunbrig is a selective next-generation tyrosine kinase inhibitor that targets ALK genetic alterations detected by the Vysis assay. The European Commission approved the drug for the same indication in April. The therapy was first approved in the US in 2017 for patients with ALK-positive metastatic NSCLC who had disease progression on, or were intolerant of, Pfizer’s Xalkori (crizotinib). The drug was granted breakthrough and orphan designations and received a priority review and assessment aid from FDA.
VESIcare LS approved as an oral suspension for overactive bladder in children

An oral suspension form of Astellas Pharma’s muscarinic antagonist, VESIcare LS (solifenacin succinate), was approved by FDA on 26 May for the treatment of neurogenic detrusor overactivity, a form of bladder dysfunction related to neurologic impairment, in children aged 2 years and older.
A tablet form of the therapy was initially approved in 2004 for the treatment of overactive bladder in adults 18 years or older.
Kynmobi okayed for treating ‘off’ episodes of Parkinson’s

The FDA has approved Sunovion’s Kynmobi (apomorphine hydrochloride) as the first sublingual therapy for on-demand treatment of acute, intermittent “off” episodes in patients with Parkinson’s disease who are otherwise controlled with oral levodopa/carbidopa.
These disruptive episodes manifest as the re-emergence of the disease or a worsening of its symptoms in otherwise controlled patients, the company said in a statement released 21 May 2020. Kynmobi, a novel formulation of the dopamine agonist apomorphine, is expected to be available in the US in September 2020.
Phexxi gets the go-ahead as first nonhormonal, prescription contraceptive gel

Phexxi (lactic acid, citric acid and potassium bitartrate), a nonhormonal vaginal gel, has been approved by the FDA as an on-demand method of contraception. The gel regulates vaginal pH, maintaining it within the normal range of 3.5 to 4.5 and creating an acidic environment in which sperm cannot survive.
The manufacturer, Evofem Biosciences, said in a statement released 22 May 2020 that it will launch Phexxi in early September, together with a comprehensive telemedicine support system to educate providers about the product and provide women with quick and easy access to Phexxi.

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