• linkedin
  • Increase Font
  • Sharebar

    New Parkinson's drug, 2 others approved

    FDA approved safinamide (Xadago, Newron Pharmaceuticals) tablets as an add-on treatment for patients with Parkinson’s disease.

    Xadago is for patients who are currently taking levodopa/carbidopa and experiencing “off” episodes, or times when a patient’s medications are not working well, which causes an increase in Parkinson’s symptoms, such as tremor and difficulty walking.

    “Parkinson’s is a relentless disease without a cure,” said Eric Bastings, MD, deputy director of the Division of Neurology Products in FDA’s Center for Drug Evaluation and Research, in a statement from FDA. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

    Related: First drug approved for hallucinations in Parkinson’s

    An estimated 50,000 Americans are diagnosed with Parkinson’s disease annually according to the National Institutes of Health, and about 1 million Americans have the condition.

    The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo.

    The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

    In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

    FDA also recently approved pembrolizumab (Keytruda, Merck) for adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after 3 or more prior lines of therapy.

    Related: First drug for rare skin cancer wins approval

    Under FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and durability of response.

    The approval is based on data in 210 patients from the KEYNOTE-087 trial, which demonstrated an overall response rate (ORR) with Keytruda (200 mg every 3 weeks) of 69%, along with a complete remission rate (CRR) of 22% and a partial remission rate (PRR) of 47%.

    The median follow-up time was 9.4 months. Among the 145 responding patients, the median duration of response was 11.1 months.

    “Today’s approval—the first for Keytruda in a hematologic malignancy—reinforces the hope that immunotherapy will prove useful in a wide variety of cancers,” said Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, in a statement from the company.

    Meanwhile, FDA also granted breakthrough therapy designation status to rituximab (Rituxan, Genentech) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.

    Genentech is currently enrolling a phase 3 study in pemphigus vulgaris (PEMPHIX, NCT02383589), a disease for which there are limited treatment options.

    “People with pemphigus vulgaris need more options and we look forward to working with the FDA to make Rituxan available to patients with this potentially deadly disease,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, in a Genentech statement. “We are committed to developing therapies that target B cells in areas of unmet need across a range of immune and malignant diseases, including new antibody constructs that enhance efficacy, safety or both.”

    Breakthrough therapy designation status was granted based on data from a Roche-supported randomized trial conducted in France, which evaluated Rituxan plus oral corticosteroid (CS) treatment compared to CS as a first-line treatment in patients with moderate to severe pemphigus.

    Results of the study, published in The Lancet, show that Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.

    Read more: FDA green lights first treatment for rare spinal disease


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • Anonymous
      In April of last year, i started on natural parkinsons disease herbal treatments from RICH HERBS FOUNDATION, i am happy to report this PD herbal treatment worked very effectively. My parkinson is totally under control, i had a total decline in symptoms, the tremors, shaking, stiffness, congnition and speech problems stopped. Visit rich herbs foundation official web page w w w. r i c h h e r b s f o u n d a t i o n. c o m. My family are amazed at the change and rapid recovery from pd.
    • [email protected]
      I am a 49-year-old man. My Parkinson's disease appeared at the age of 47. My symptoms, at the beginning, were fine tremors and rigidity with joint stiffness. My neurologist prescribed entacapone with levodopa, carbidopa, and pramipexole. I opted not to go on prescription medicines but decided on using herbs instead, October 18, 2017 after being on the herbs you recommended, i had a total recovery from Parkinson’s disease with this natural herbal formula treatment. The tremors, Shaking, Joint Stiffness has subsided. When I stumbled upon you guys, it was just pure instinct. And from that day on it has been one of the best decisions I’ve made in my life. The caring that goes into explaining what herbs work for whatever ails me is astounding. In today’s world where so many are after a quick buck, selling without care, The Herbal Garden’s staffs amplifies the difference. I’m a believer in karma, and for generations to come, this is a herbal store that will be leaving it’s footprint in this world. Visit THE HERBAL GARDENS official web site www. theherbalgardens. org A world of thanks to The Herbal Gardens!”
    • [email protected]
      I was diagnosed with polymyositis in 2002 and idiopathic pulmonary fibrosis (IPF) by a lung biopsy in 2007. I have been on prednisone at various dosages from the beginning along with various immune suppressant medications. I began taking tacrolimus in 2008 and have held off any progression of more scarring. I had shortness of breath and coughing. I was relatively active but I learned to pace myself. I have the best medical team that all work together.. As the disease progressed all medication stopped working, i was introduced to Health herbal clinic in South Africa who have successful herbal treatment to Pulmonary fibrosis and other lungs diseases. I spoke to few people who used the treatment here in USA and they all gave a positive response, so i immediately purchased the Pulmonary fibrosis herbal remedy and commenced usage, i used the herbal supplement for only 9 weeks, all symptoms gradually faded away, herbs are truly gift from God. contact this herbal clinic via their email healthherbalclinic @ gmail. com or visit www. healthherbalclinic. weebly. com