ARDSLEY, NY, USA I July 26, 2019 I Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA’s approval by the European Commission (EC). The recommended indication is: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. The European Commission (EC) will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for INBRIJA in Europe; the final EC decision is expected in the coming months. The review of this application is being conducted under the centralized licensing procedure, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
INBRIJA was approved by the U.S. Food and Drug Administration on December 21, 2018 for the intermittent treatment of OFF episodes (also known as OFF periods) in people with Parkinson’s disease treated with carbidopa/levodopa.
“We are delighted that INBRIJA has achieved this important milestone, and look forward to the EC’s final decision later this year. There are approximately 1.2 million people in the EU living with Parkinson’s. We estimate that 40% of these individuals experience OFF periods, which are considered extremely disruptive,” said Ron Cohen, M.D., Acorda’s President and CEO. “Acorda is currently evaluating partnering opportunities to commercialize INBRIJA in Europe.”
The positive CHMP decision is based on a clinical program for INBRIJA that included approximately 900 people with Parkinson’s on a levodopa/dopa-decarboxylase inhibitor regimen experiencing OFF periods. The results of the Phase 3 pivotal efficacy trial – SPANSM-PD – were published in The Lancet Neurology.
SPAN-PD was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of INBRIJA in patients with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the Week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for INBRIJA 84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). Onset of action was seen as early as 10 minutes.
The most common adverse reactions with INBRIJA (at least 5% and greater than placebo) in this pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum discolored (5% vs. 0%).
INBRIJA was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study (N=398) assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (-0.1 L) for the INBRIJA and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last five years were excluded from this study.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA is a prescription medicine used for the return of Parkinson’s symptoms (known as OFF episodes) in adults treated with carbidopa-levodopa medicines. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
About Parkinson’s and OFF Periods
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons in the brain. These neurons are responsible for producing dopamine and that loss causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson’s progresses, people are likely to experience OFF periods, which are characterized by the return of Parkinson’s symptoms, which can occur despite underlying baseline therapy. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; it is estimated that approximately 40 percent of people with Parkinson’s in the U.S. experience OFF periods.
About INBRIJA (levodopa inhalation powder)
INBRIJA is the first and only inhaled levodopa for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS platform for inhaled therapeutics.
SOURCE: Acorda Therapeutics
Post Views: 26
ARDSLEY, NY, USA I July 26, 2019 I Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending INBRIJA’s approval by the European Commission (EC). The recommended indication is: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (off episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor. The European Commission (EC) will now consider the CHMP positive opinion in its decision of whether to grant marketing authorization for INBRIJA in Europe; the final EC decision is expected in the coming months. The review of this application is being conducted under the centralized licensing procedure, and the final decision will be applicable in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
INBRIJA was approved by the U.S. Food and Drug Administration on December 21, 2018 for the intermittent treatment of OFF episodes (also known as OFF periods) in people with Parkinson’s disease treated with carbidopa/levodopa.
“We are delighted that INBRIJA has achieved this important milestone, and look forward to the EC’s final decision later this year. There are approximately 1.2 million people in the EU living with Parkinson’s. We estimate that 40% of these individuals experience OFF periods, which are considered extremely disruptive,” said Ron Cohen, M.D., Acorda’s President and CEO. “Acorda is currently evaluating partnering opportunities to commercialize INBRIJA in Europe.”
The positive CHMP decision is based on a clinical program for INBRIJA that included approximately 900 people with Parkinson’s on a levodopa/dopa-decarboxylase inhibitor regimen experiencing OFF periods. The results of the Phase 3 pivotal efficacy trial – SPANSM-PD – were published in The Lancet Neurology.
SPAN-PD was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of INBRIJA in patients with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the Week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score for INBRIJA 84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points respectively; p=0.009). Onset of action was seen as early as 10 minutes.
The most common adverse reactions with INBRIJA (at least 5% and greater than placebo) in this pivotal trial were cough (15% vs. 2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum discolored (5% vs. 0%).
INBRIJA was also studied in a Phase 3 long-term, active-controlled, randomized, open-label study (N=398) assessing safety and tolerability over one year. This study showed the average reduction in FEV1 (forced expiratory volume in 1 second) from baseline was the same (-0.1 L) for the INBRIJA and observational cohorts. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last five years were excluded from this study.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA is a prescription medicine used for the return of Parkinson’s symptoms (known as OFF episodes) in adults treated with carbidopa-levodopa medicines. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
About Parkinson’s and OFF Periods
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons in the brain. These neurons are responsible for producing dopamine and that loss causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson’s progresses, people are likely to experience OFF periods, which are characterized by the return of Parkinson’s symptoms, which can occur despite underlying baseline therapy. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; it is estimated that approximately 40 percent of people with Parkinson’s in the U.S. experience OFF periods.
About INBRIJA (levodopa inhalation powder)
INBRIJA is the first and only inhaled levodopa for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS platform for inhaled therapeutics.
SOURCE: Acorda Therapeutics
Post Views: 26
