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After more than 2 decades, the FDA has approved the second drug to treat amyotrophic lateral sclerosis (ALS). Edaravone (Radicava), granted approval on Friday, is an intravenous infusion that is administered by a health care professional. According to a press release, the initial treatment cycle consists of a daily dosing for 14 days followed by a 14-day drug free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days being drug free. The approval was based on a 6-month clinical trial in Japan that included 137 patients who were randomized to receive either edaravone or placebo. The results of the study showed that at week 24, patients who received edaravone declined less on a clinical assessment of daily functioning compared with patients who received the placebo. The most common adverse events were bruising or gait disturbance.
In the midst of an opioid epidemic that kills more than 47,000 individuals per year in the United States, President Donald Trump’s 2018 fiscal budget proposal would cut approximately 95% of funding for the Office of National Drug Control Policy (ONDCP). According to Politico, the planned cut would reduce funding from $388 million in fiscal 2017 to $24 million in fiscal 2018. Furthermore, it would put an end to the ONDCP’s drug free communities and high-intensity drug trafficking programs, which have bipartisan support in congress. Although a White House budget official declined to comment, they stressed that the proposal is still under review and that the administration is still committed to “winning the war on drugs,” according to Politico.
On Sunday, former President Barack Obama urged members of Congress to have the “political courage” to not repeal the Affordable Care Act, according to Politico. Obama’s first public comments regarding the American Health Care Act comes in the wake of the law passing in the House last week by a vote of 217 to 213. During his acceptance speech for the Profiles in Courage award at the John F. Kennedy Library, Obama said, “I hope they understand that courage means not simply doing what’s politically expedient, but doing what, deep in our hearts, we know is right.”