Drugs in the Pipeline
The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment.
Both filings have been granted Priority Review by the Agency.
In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells.
While the exact mechanism of action of cenobamate is not fully understood, it is believed to work through a dual mechanism.
Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis.
Alkermes plans to meet with the FDA to discuss next steps for ALKs 5461.
Currently, there are no approved therapies for the treatment of MSA, a rare progressive neurodegenerative disease.
Crenezumab is an investigational monoclonal antibody that preferentially binds to and promotes the removal of neurotoxic oligomers, a form of beta-amyloid.
Previous Phase 2 studies confirmed esterol has minimal impact on liver cells and metabolic pathways, as well as on coagulation parameters.
Phase 3 studies investigating safety, tolerability, and immunogenicity in both adults and children are currently underway.
Tanezumab is a humanized monoclonal antibody that selectively targets, binds to, and inhibits nerve growth factor (NGF).
The TIDES trial is investigating the safety and efficacy of 2 doses of TAK-003 in preventing dengue fever caused by any of the 4 dengue virus serotypes.
This investigational treatment was evaluated in 42 HS patients, of which 24 had previously failed anti-tumor necrosis factor (TNF) therapy.
Once-daily Pifeltro and Delstrigo were initially approved in August 2018 to treat HIV-1 infection in adults with no prior antiretroviral treatment experience.
Currently, there is no FDA-approved treatment for biliary atresia, a rare pediatric liver disease.
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NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)