Keeping tabs on pharma: FDA fast tracks Novartis osteoarthritis drug and grants approval for Janssen’s long-acting schizophrenia drug
New Novartis drug proves ground-breaking for the treatment of osteoarthritis and Janssen promises to improve the quality of life for schizophrenia patients
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Novartis LNA043 receives FDA fast track status
Novartis LNA403, an early experimental drug designed to treat osteoarthritis-related cartilage damage and inflammation, has received fast track status from the US Food and Drug Administration (FDA).
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Fast track is a designation that expedites the review process for an investigational drug and is used when this drug treats a serious or life-threatening condition and fulfills an unmet medical need.
LNA403 is a disease-alerting therapy for osteoarthritis that acts to treat injured cartilage by regulating certain pathways related to cartilage regeneration. Following a proof-of-concept trial, it was revealed that intra-articular injections of LNA043 succeeded in the regeneration of injured cartilage in patients with femoral articular cartilage lesions.
“[Osteoarthritis is] a debilitating disease with increasing prevalence as societies age and existing pharmacologic treatments only address symptoms such as pain. There is a significant and growing need for a disease-modifying therapy that could maintain or regenerate cartilage and change the natural course of the disease,” a spokesperson at Novartis explained.
A Phase 2 trial is currently underway, having begun in September 2017, and is expected to conclude in September 2022. With current treatment for osteoarthritis only targeting pain, Novartis claimed the final approval of this drug would add a much needed medicine to the arsenal of healthcare practitioners tasked with treating osteoarthritis patients.
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Janssen’s twice-yearly schizophrenia drug receives FDA approval
The past week has seen a major advancement in the field of anti-psychotic drug development. Janssen’s Invega Hafyera, the first-ever twice-yearly injectable drug has attained FDA approval. The drug is intended for those who have been treated with the current standard medicines, a one-month paliperidone palmitate called Invega Sustenna and a three-month paliperidone palmitate called Invega Trinza.
Approval came following a successful 12-month, double-blind, international Phase 3 clinical trial, which tested the drug on over 700 adult schizophrenia patients aged between 18 and 70 years. The trial revealed that despite the reduced injection frequency, Invega Hafyera demonstrated non-inferiority against Inevga Trinza, with an end-of-year relapse rate of only 7.5 percent.
Bill Martin, Head of Research and Development Neuroscience Global Therapeutic Area at Janssen, suggested that the drug could significantly improve the lives of schizophrenia patients.
“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates and sustained treatment over longer periods,” he explained. “Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”
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