Month: October 2016
FDA Approves Janssen’s STELARA for the Treatment of Adults With Moderately to Severely Active Crohn’s Disease
Janssen Biotech Inc. received approval from the U.S. FDA for STELARA (ustekinumab), used for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older). The drug is for the patients who have failed or were intolerant to treatment with immune-modulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA® is broadly accessible and affordable for patients.
Novartis announces AMG 334 significantly reduces monthly migraine days in people with episodic migraine
Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The Phase III study met its primary endpoint, showing a statistically significant reduction in monthly migraine days vs placebo.
AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
AbbVie, a global biopharmaceutical company, got Breakthrough Therapy Designation (BTD) from the U.S. FDA for pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P), which is used for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor. The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study.
PaizaBio Gains CFDA Approval to Expand Fill/Finish Capacity
PaizaBio gained approval from China’s FDA (CFDA) to add new aseptic injectable production capability at it production facility in Hangzhou, China. This expansion will increase the company’s annual fill/finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges. The capacity will focus on small molecule drugs for clinical trials and small batch production and the company anticipates reaching full-scale production by 1Q17.
WuXi Biologics completes construction of Asia’s largest perfusion biologics manufacturing facility using disposable bioreactors
WuXi Biologics, an open-access R&D capability and technology platform company, has announced the opening of a new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. The new facility accommodates two 1000L disposable bioreactors for perfusion processes and is the largest perfusion biologics manufacturing facility to date in Asia implementing disposable bioreactors.
Plaque psoriasis is a chronic autoimmune condition, with a buildup of dead cells as scales giving the affected area of skin a raised and red patchy look. About 2% of population in the US suffers from this disease. A new drug, Taltz (Ixekizumab), has been approved by FDA in March 2016 for its treatment.
Taltz (ixekizumab), a selective humanized IgG4 monoclonal antibody, was developed by Eli Lily and Company and inhibits the interaction of interleukin 17A (IL-17A) cytokine and IL-17 receptor by binding to 17A (IL-17A) cytokine. This inhibitory effect of Taltz neutralizes IL-17, IL-14, IL-21, thus blocking beta-defensins, keratinocyte production of cytokines and antimicrobial peptides (AMPs).
Some of the drugs available in the market include Humira, Cosentyx, Enbrel, Otezla, Taclonex, Stelara, and Dovonex. Cosentyx, a Novartis product, was approved in Europe and US in 2015. This was the first fully human interleukin 17A inhibitor launched in market, but since its launch it hasn’t been able to make a mark on the plaque psoriasis market. Brodalumab, a potential competitor after its expected launch in 2016, couldn’t make it to the market because of the side effects, which included depression and suicidal thoughts.
In the year 2015, Cosentyx, Stelara, Enbrel and Humira had shown sales of USD 261 million, USD 742 million, USD 5.364 billion, and USD 14.012 billion respectively. As per the current trends, Enbrel, Cosentyx and Humira are good competitors of Taltz for this indication. Enbrel was the most prescribed drug for this indication but due to Taltz’s good Phase III trial results, the latter might overtake sales in the market. Since there is no effective therapy that treats psoriasis properly, this poses to be the most important unmet need.
DelveInsight Business Research