The FDA has approved an add-on medication for Parkinson’s disease, Newron Pharmaceutical’s Xadago (safinamide), bringing to an end the US approval process that saw a long back-and-forth between the FDA and Newron Pharmaceuticals. Xadago is the first new chemical entity for the treatment of Parkinson’s that has gained FDA approval in over a decade, and there are hopes this approval could kick-start further research into this debilitating neurodegenerative disease.

Xadago has been approved for use as a supplementary drug to other Parkinson’s medications, particularly levodopa and carbidopa. Its main use is for patients who are experiencing an “off” episode, a period when the primary drug is not working. In clinical trials, the drug has been shown to increase “on” time when symptoms are reduced.

Xadago has been approved in 10 European markets since 2015, including Germany, the UK, Spain, and Italy, but suffered several setbacks in its FDA approval filing. A New Drug Application (NDA) was first filed in May 2014 but was not accepted due to organizational issues. The NDA was subsequently resubmitted in November 2015, but a Complete Response Letter was issued in March 2016 in which the FDA noted concerns regarding the abuse potential of the drug, as well as its dependence/withdrawal effects.

Finally, after Newron’s latest clinical trial, the FDA concluded that Xadago was shown to be effective as a complementary treatment to levodopa in 645 Parkinson’s patients who were experiencing worsening symptoms, and granted approval for the drug.

Xadago is a monoamine oxidase B (MAO-B) inhibitor and, due to the approval setbacks, is a late entrant to the MAO-B space. Xadago’s main competitor is Teva’s Azilect (rasagiline), which is already well established in the market. However, Xadago exhibits a dual mechanism of action, targeting both MAO-B and glutamate release, which is thought to provide additional therapeutic benefit, although this has not been tested in clinical trials. Xadago has also shown to have much greater selectivity for MAO-B over MAO-A, which limits adverse effects. In addition, Azilect’s US patent expiration in January 2017 could have a positive impact on Xadago’s sales.

These competitive advantages, as well as Newron’s experience with commercialization in Europe, puts Xadago in a strong position to gain a significant share of the Parkinson’s disease supplementary drug market.

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