PDUFA date by December 29, 2015
MILAN, Italy I March 2, 2015 I Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel central nervous system (CNS) and pain therapies, and its commercial and development partner, Zambon S.p.A., an international pharmaceutical company, announced today that the New Drug Application (NDA) for Xadago® (safinamide) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of December 29, 2015 to complete its review of the NDA.
The application covers the proposed use of Xadago® (safinamide) as add-on therapy in both early and mid-to-late stage Parkinson’s disease patients who are inadequately managed on their current treatment.
“The acceptance of the NDA submission for review is based on extensive inputs received from the FDA during the last six months. This decision indicates that the process of review of the comprehensive efficacy and safety data on Xadago can proceed expeditiously, and brings Xadago® closer to becoming available for patients in the U.S.,” said Ravi Anand, M.D., Newron’s Chief Medical Officer. “If approved by the FDA, Xadago® will provide an innovative add-on treatment option for patients during all stages of Parkinson’s disease.”
“We are in late stage negotiations with interested potential partners for Xadago® in the U.S.”, said Maurizio Castorina, Chief Executive Officer at Zambon. “And subject to FDA approval, Zambon expects the commercial launch of this New Chemical Entity by our North American partner in the first quarter of 2016.”
The acceptance of the NDA by the FDA follows the Marketing Authorization by the EU Commission for Xadago® for the treatment of Parkinson´s disease in the EU, adopted on February 24, 2015.
About Parkinson’s disease
Parkinson’s disease (PD) is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals age 65 years and older worldwide. The prevalence of the PD is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on the observational criteria of muscular rigidity, resting tremor or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on levodopa (L-dopa). L-dopa remains the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms such as dyskinesia that are not improved by current dopaminergic therapies.
About Xadago®
Xadago® (safinamide), an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease (PD). It has both dopaminergic and non dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on the research and development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. In addition to Xadago® for Parkinson’s disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome, sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is also developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
About Zambon
Zambon is a leading Italian pharmaceutical and fine-chemical multinational company that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and woman care, and is very strongly committed to its entry into the CNS space. Zambon SpA produces high quality products thanks to the management of the whole production chain which involves Zach (Zambon chemical), a privileged partner for API, custom synthesis and generic products. The Group is strongly working on the treatment of the chronic respiratory diseases as asthma and BPCO and on the CNS therapeutic area with Xadago® (safinamide) for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with subsidiaries and more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 73 countries.
SOURCE: Zambon
Post Views: 28
PDUFA date by December 29, 2015
MILAN, Italy I March 2, 2015 I Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel central nervous system (CNS) and pain therapies, and its commercial and development partner, Zambon S.p.A., an international pharmaceutical company, announced today that the New Drug Application (NDA) for Xadago® (safinamide) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of December 29, 2015 to complete its review of the NDA.
The application covers the proposed use of Xadago® (safinamide) as add-on therapy in both early and mid-to-late stage Parkinson’s disease patients who are inadequately managed on their current treatment.
“The acceptance of the NDA submission for review is based on extensive inputs received from the FDA during the last six months. This decision indicates that the process of review of the comprehensive efficacy and safety data on Xadago can proceed expeditiously, and brings Xadago® closer to becoming available for patients in the U.S.,” said Ravi Anand, M.D., Newron’s Chief Medical Officer. “If approved by the FDA, Xadago® will provide an innovative add-on treatment option for patients during all stages of Parkinson’s disease.”
“We are in late stage negotiations with interested potential partners for Xadago® in the U.S.”, said Maurizio Castorina, Chief Executive Officer at Zambon. “And subject to FDA approval, Zambon expects the commercial launch of this New Chemical Entity by our North American partner in the first quarter of 2016.”
The acceptance of the NDA by the FDA follows the Marketing Authorization by the EU Commission for Xadago® for the treatment of Parkinson´s disease in the EU, adopted on February 24, 2015.
About Parkinson’s disease
Parkinson’s disease (PD) is the second most common chronic progressive neurodegenerative disorder in the elderly after Alzheimer’s disease, affecting 1-2% of individuals age 65 years and older worldwide. The prevalence of the PD is expected to grow in the next years due to the increase in the global population and advancements in healthcare that contribute to an aging population at increased risk for PD. The diagnosis of PD is mainly based on the observational criteria of muscular rigidity, resting tremor or postural instability in combination with bradykinesia. As the disease progresses, symptoms become more severe. Early-stage patients are more easily managed on levodopa (L-dopa). L-dopa remains the most effective treatment for PD, and over 75% of the patients with PD receive L-dopa. However, long term treatment with L-dopa leads to seriously debilitating motor fluctuations, i.e. phases of normal functioning (ON-time) and decreased functioning (OFF-time). Furthermore, as a result of the use of high doses of L-dopa with increasing severity of the disease, many patients experience involuntary movements known as L-dopa-Induced Dyskinesia (LID). As the disease progresses, more drugs are used as an add-on to what the patient already takes, and the focus is to treat symptoms while managing LID and the “off-time” effects of L-dopa. Most current therapies target the dopaminergic system that is implicated in the pathogenesis of PD, and most current treatments act by increasing dopaminergic transmission that leads to amelioration of motor symptoms. There is a growing belief that targeting non-dopaminergic systems may lead to improvements in PD symptoms such as dyskinesia that are not improved by current dopaminergic therapies.
About Xadago®
Xadago® (safinamide), an alpha-aminoamide, is currently being developed by Newron as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease (PD). It has both dopaminergic and non dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro.
About Newron Pharmaceuticals
Newron (SIX: NWRN) is a biopharmaceutical company focused on the research and development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. The Company is headquartered in Bresso near Milan, Italy. In addition to Xadago® for Parkinson’s disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome, sNN0031 for patients with Parkinson’s disease, non-responsive to oral drug treatments, sNN0029 for patients with ALS and ralfinamide for patients with specific rare pain indications. Newron is also developing NW-3509 as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
About Zambon
Zambon is a leading Italian pharmaceutical and fine-chemical multinational company that has earned a strong reputation over the years for high quality products and services. Zambon is well-established in 3 therapeutic areas: respiratory, pain and woman care, and is very strongly committed to its entry into the CNS space. Zambon SpA produces high quality products thanks to the management of the whole production chain which involves Zach (Zambon chemical), a privileged partner for API, custom synthesis and generic products. The Group is strongly working on the treatment of the chronic respiratory diseases as asthma and BPCO and on the CNS therapeutic area with Xadago® (safinamide) for the Parkinson treatment. Zambon is headquartered in Milan and was established in 1906 in Vicenza. Zambon is present in 15 countries with subsidiaries and more than 2,600 employees with manufacturing units in Italy, Switzerland, France, China and Brazil. Zambon products are commercialized in 73 countries.
SOURCE: Zambon
Post Views: 28
