Update for the Week Ending February 15, 2020

Subscribers of the Prescribe Right Pharmaceutical Pipeline Tracker can now keep up with Coronavirus developments. We have added monographs for COVID-19 vaccines from Johnson & Johnson and Moderna. We have added monographs for the nucleotide analogue remdesivir and the monoclonal antibody being developed by Regeneron. Coronavirus and COVID-19 have been added as indication search terms to make it easy to determine if new drugs or vaccines have been added to combat the virus. Subscribe today and stay informed.
 
Regulatory Update
 
The FDA approved lactitol (Pizensy, Braintree Laboratories) on 2/13/2020 for the treatment of chronic idiopathic constipation in adults.
 
The FDA accepted the NDAs for:

• KTE-X19 for the treatment of relapsed or refractory mantle cell lymphoma and set a PDUFA date of 8/10/2020.
• Capmatinib for the treatment of locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer and set a PDUFA date of 8/11/2020.
• Ripretinib for the treatment of advanced gastrointestinal stromal tumors and a set a PDUFA date of 8/13/2020.
• Lisocabtagene maraleucel for the treatment of large B-cell lymphoma and a set a PDUFA date of 8/17/2020.
• Viltolarsen for the treatment of Duchenne muscular dystrophy amenable to exon 53 skipping and a set a PDUFA date of 8/13/2020. If approved, viltolarsen will compete with golodirsen, which was approved in December 2019 for the same indication.
• Tucatinib for the treatment of locally advanced or metastatic HER-2 positive breast cancer and a set a PDUFA date of 8/20/2020.
• Roxadustast for the treatment of both dialysis-dependent and non-dialysis dependent anemia and a set a PDUFA date of 12/20/2020.
  

The FDA granted Fast Track status to NBTXR3 for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.
 
Trevena resubmitted an NDA for oliceridine for the management of moderate-to-severe acute pain.
 
Announced Research Updates
 
Lilly announced that in the 5-year, 194 patient, Phase II/III, DIAN-TU trial, neither solanezumab nor gantenerumabslowed the loss of cognition compared to placebo in patients at risk for dominantly inherited Alzheimer's disease.
 
Abeona announced interim results from 3 patients enrolled in the Phase I/II, open-label, Transpher A trial, where treatment with ABO-102 resulted in neurocognitive development within normal age equivalent parameters 18-24 months post treatment in patients with Sanfilippo syndrome type A (MPS IIIA).
 
Abeona announced interim results from 7 patients enrolled in the Phase I/II, open-label, Transpher B trial, where treatment with ABO-101 resulted in improvements in biomarkers associated with abnormal accumulation of glycosaminoglycans in the brain and throughout the body neurocognitive development within normal age equivalent parameters 18-24 months post treatment in patients with Sanfilippo syndrome type B (MPS IIIB).
 
Published Research Updates
 
In a 6-month, 76 patient, Phase II, open-label trial, treatment with bevacizumab plus buparlisib resulted in progression free survival of 4 months and an overall response rate of 26%, which is similar to historical bevacizumab monotherapy, but with a higher rate of adverse effects in the treatment of patients with relapsed/refractory glioblastoma.
 
In a 27 patient, Phase Ib/II, open-label trial, treatment with tivozanib resulted in a progression-free interval of 24 weeks and an overall response rate of 21% in patients with inoperable hepatocellular carcinoma. 
 
In a 4-week, 375 patient, Phase IIb, dose-ranging trial, treatment with ensifentrine improved FEV1 compared to placebo by 146mL with 0.75mg, 153 mL with 1.5 mg, 200 mL with 3 mg and 139 mL with 6 mg in patients with COPD.
 
In a 7-week, 450 patient, Phase II, dose-ranging trial, mirogabalin did not improve the average daily pain score compared to pregabalin or placebo in Asian patients with diabetic peripheral neuropathic pain.
 
In the 253 patient, Phase II, INCREASE trial, treatment with icotinib 250 mg TID resulted in a progression-free survival of 12.9 months compared to 9.2 months with icotinib 125 mg TID in patients with non-small cell lung cancer harboring 21-L858R mutation.