Krystle Vermes

The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10-mg). The agency’s Division of Bioequivalence determined the product is the bioequivalent of Amprya from Acorda Therapeutics, and it is indicated for the treatment of multiple sclerosis (MS).

Amprya’s main ingredient is dalfampridine, which works to block potassium channels in the body. In turn, MS patients may see an improvement in walking and an increase in walking speed.

The most common adverse effects associated with Amprya are urinary tract infection, insomnia, dizziness, headache, nausea, weakness, and back pain.

The drug may cause seizures in some patients. In studies, those who used 20-mg of Amprya twice daily showed an increased incidence of seizures. The drug has not been studied in patients with a history of seizures.

Aurobindo’s product portfolio now consists of 256 final approvals, including 39 tentative approvals and 16 approved products from Aurolife.

  The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10-mg). The agency’s Division of Bioequivalence determined the product is the bioequivalent of Amprya from Acorda Therapeutics, and it is indicated for the treatment of multiple sclerosis (MS).

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Dalfampridine extended-release tablets deemed bioequivalent of Amprya.

Amprya Bioequivalent Approved for Multiple Sclerosis

Dalfampridine extended-release tablets is the bioequivalent of Amprya.

Bioequivalent Multiple Sclerosis Drug Approved by FDA

The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg). The agency’s Division of Bioequivalence determined the product is the bioequivalent of Ampyra from Acorda Therapeutics, and it is indicated for the treatment of multiple sclerosis (MS).

Ampyra’s main ingredient is dalfampridine, which works to block potassium channels in the body. In turn, MS patients may see an improvement in walking and an increase in walking speed.

The most common adverse effects associated with Ampyra are urinary tract infection, insomnia, dizziness, headache, nausea, weakness, and back pain.

The drug may cause seizures in some patients. In studies, those who used 20 mg of Ampyra twice daily showed an increased incidence of seizures. The drug has not been studied in patients with a history of seizures.

The FDA has given final approval to Aurobindo Pharma Limited for dalfampridine extended-release tablets (10 mg). 

FDA Approves Ampyra Bioequivalent for Multiple Sclerosis

Researchers at the University of California San Diego School of Medicine, along with colleagues from the National Institute of Diabetes and Digestive and Kidney Diseases, the University of Manitoba and St. Boniface Hospital Albrechtsen Research Centre, have discovered a potential treatment for peripheral neuropathy.

the researchers demonstrated a way to promote sensory neuron growth by blocking a specific molecular signaling pathway. The blockage also prevented or reversed peripheral neuropathy in cell and rodent models of type 1 and 2 diabetes, chemotherapy-induced neuropathy, and HIV. Muscarinic acetylcholine receptors appear to be responsible for inhibiting the growth of sensory neurons, and a number of antimuscarinic drugs are already on the market.

“This is encouraging because the safety profile of anti-muscarinic drugs is well-characterized, with more than 20 years of clinical application for a variety of indications in Europe,” senior study author Paul Fernyhough, PhD, professor in the departments of pharmacology and therapeutics and physiology at the University of Manitoba, said in a press release. “The novel therapeutic application of anti-muscarinic antagonists suggested by our studies could potentially translate relatively rapidly to clinical use.”

Approximately 20 million Americans are thought to have some form of peripheral neuropathy. It can lead to symptoms such as numbness, muscle weakness, and severe pain.

Blocking Neuron Signaling Pathway Could Lead to New Treatments for Peripheral Neuropathy [news release]. UCSD’s website. 

https://health.ucsd.edu/news/releases/Pages/2017-01-17-blocking-neuron-signaling-pathway-could-lead-to-peripheral-neuropathy-treatment.aspx

In a study published in the Journal of Clinical Investigation, the researchers demonstrated a way to promote sensory neuron growth by blocking a specific molecular signaling pathway. 

Researchers Find New Way to Inhibit Sensory Neuron Growth

The FDA has approved Imbruvica (ibrutinib) for the treatment of marginal zone lymphoma (MZL) in patients who require systemic therapy, or in those patients who have received at least 1 anti-CD20-based therapy. The approval was based on the product’s apparent overall response rate in a phase 2 trial.

The PCYC-1121 trial assessed the safety and efficacy of Imbruvica in 63 patients with MZL, who had received at least 1 prior therapy. Their responses to the investigational product were assessed by an independent review committee, utilizing criteria from the International Working Group criteria for malignant lymphoma. There was a 46% overall response rate in patients, and 3.2% of participants achieved complete responses.

"Patients with relapsed/refractory marginal zone lymphoma are in critical need of treatment options to manage living with this rare, serious blood cancer," Ariela Noy, MD, Hematologic Oncologist at Memorial Sloan Kettering Cancer Center and lead investigator of the study, said in a press release. "This approval of Imbruvica represents a welcome new oral option for the MZL community and is the first approved therapy for these patients."

Some of the adverse effects associated with Imbruvica are thrombocytopenia, fatigue, anemia, diarrhea, bruising, musculoskeletal pain, and nausea.

The FDA has approved Imbruvica (ibrutinib) for the treatment of marginal zone lymphoma.

FDA Approves Imbruvica for the Treatment of Marginal Zone Lymphoma in Some Patients

The FDA has accepted the new drug application (NDA) for EZR-201, an investigational product from Ezra Innovations for the treatment of hypertension and heart failure. EZR-201 combines an angiotensin receptor blocker, valsartan, with Rubireten delivery technology.

The 505(b)(2) NDA was filed to the FDA with clinical data from 2 pharmacokintetic studies, as well as 1 clinical trial involving patients with stage 2 hypertension. There was also information on the clinical use of valsartan over the course of 20 years.

The Rubireten delivery technology is based on solubilisation and gastric retention. It allows for a more controlled drug release in the body, ensuring that chemicals reach maximum absorption.

"The FDA acceptance of our NDA for EZR-104 is an important milestone, and brings us closer to offering patients an attractive alternative treatment option for people in the U.S. with hypertension and heart failure," Joseph Fix, PhD, President and Chief Operating Officer at Ezra, said in a press release. "We continue to evaluate our strategic options for commercialization of EZR-104 in the United States, which include partnership, internal approaches, or a combination of these."

The Prescription Drug User Fee Act goal date for EZR-201 has been set for September 10, 2017. The most recent FDA acceptance indicates that the application is complete enough to receive a substantive review. 

EZR-201 combines an angiotensin receptor blocker, valsartan, with Rubireten delivery technology for the treatment of hypertension and heart failure.