Update for January 25, 2022

New Drugs Added to Knowledgebase
 
Last week we added 10 new drugs to the knowledgebase:

• Aficamten, a cardiac myosin inhibitor for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
• Arazasetron, a 5-HT3 receptor antagonist for the treatment of Sudden sensorineural hearing loss, platinum-induced ototoxicity
• Elacestrant, a selective estrogen receptor degrader (SERD) for the treatment of Breast cancer
• Datopotamab deruxtecan, an antibody drug conjugate (ADC) for the treatment of non-small cell lung cancer, Triple negative breast cancer, HR positive/HER2 negative breast cancer, small cell lung cancer, urothelial and gastrointestinal cancers
• Eplontersen, an antisense drug for the treatment of ATTR amyloidosis 
• BLU-5937, a P2X3 antagonist for the treatment of chronic cough, chronic pruritus
• IMGN632, an antibody drug conjugate (ADC) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML)
• YTB323, a CAR-T cell Therapy for the treatment of B-cell lymphoma
• PHE885, a CAR-T cell Therapy for the treatment of multiple myeloma
• Tabelecleucel, an allogeneic T-cell immunotherapy for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease

The Prescribe Right Pharmaceutical Pipeline Tracker now allows you to track 980 pipeline and recently approved drugs supported by 2.364 published and announced research results.
 
Regulatory Update
 
The FDA rejected Levo Therapeutics’ intranasal carbetocin for the treatment of Prader-Willi syndrome and requested an additional Phase III trial.
 
Pfizer announced the FDA rejected somatrogon, but did not provide a reason for the rejection.
 
The FDA rejected Merck’s gefapixant for the treatment of chronic cough and requested additional information related to measurement of efficacy. 
 
The FDA delayed the PDUFA date by three months for Bluebird Bio’s betibeglogene autotemcel, to treat transfusion-dependent beta-thalassemia, to allow more time to review additional clinical information
 
The FDA delayed the PDUFA date by three months for Bluebird Bio’s elivaldogene tavalentivec, to treat cerebral adrenoleukodystrophy, to allow more time to review additional clinical information
 
The FDA recommended that GenSight conduct an additional trial for lenadogene nolparvovec due to the unexpected bilateral vision improvement seen in unilaterally treated Leber Hereditary Optic Neuropathy patients in the RESCUE, REVERSE and REFLECT trials.
 
Announced Research Updates
 
Results from two Phase III bimekizumab trials; the axial spondyloarthritis BE MOBILE 1 trial and the psoriatic arthritis BE COMPLETE trial 
 
Results from the HIMALAYA trial evaluating the addition of tremelimumab to a regimen to treat advanced hepatocellular carcinoma.
 
18-month data from the HELIOS-A trial evaluating vutrisiran to treat hATTR amyloidosis 
 
Published Research Updates
 
Results from the Phase III, ECOSPOR III trial, evaluating SER-109 to prevent recurrent C. difficile infection.
 
Results from the Phase III, GEMSTONE-302 trial, evaluating sugemalimab in the treatment of metastatic squamous and non-squamous non-small cell lung cancer. 
 
Results from a triple-negative breast cancer adavosertib trial.
 
Results from an ovarian cancer evaluating cediranib
 
Two Phase III daridorexant insomnia trials
 
Four Phase III faricimab trials. Two evaluating faricimab as a treatment for neovascular age-related macular degeneration and two for diabetic macular edema.

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