2019 Trends to Watch & the Weekly Update

As we roll into 2019, we highlight some trends to watch. Additional detail available at Evaluate.com’s Vantage 2019 Previewfor an industry-wide analysis. 

• Four out of the last five years have seen a much higher than average rate of positive outcomes from the FDA, versus the 10-year average. And the agency greenlighted a record number of drugs in 2018.
• This uptick presumably largely reflects the FDA’s internal efforts to get new drugs to market more quickly and efficiently. Many believe that the jump in numbers is also a result of lower efficacy hurdles.
• FDA approvals based on surrogate endpoints have been growing.
• One space that is sure to generate news is NASH; believers reckon that the space represents a mega-blockbuster opportunity for industry.

As we highlighted in our 2018 updates another potentially very valuable but elusive therapy area is Alzheimer’s disease, and next year will undoubtedly contain updates. We list 23 investigational drugs for Alzheimer's disease in our knowledgebase.
Regarding upcoming potential budget busters, there are fifteen investigational drugs with PDUFA Dates between January and Sept 2019. Eight of these drugs have priority designations. Take a look at our “Monitoring Drugs with PDUFA Dates” Use Caseto see how the Prescribe Right Pharmaceutical Pipeline Tracker can keep you on top of these drugs.

And from the week ending January 5, 2019:

• Sanofi ended a partnership with Myokardia to develop mavacamten.
• The 14-day, 2,666 patient, Phase III, open label, RELAX‐AHF‐EU trial was terminated early due to neutral results from the RELAX‐AHF‐2 study. Serelaxin added to standard of care reduced adjudicated WHF/all‐cause death through Day 5 compared to placebo (5% vs 6.9%).  At Day 14 there was no significant difference in WHF/all‐cause death/heart failure rehospitalization.
• Viela announced that in the 231 patient, Phase III, N-MOmentum trial, treatment with inebilizumab reduced the risk of a neuromyelitis optica spectrum disorder (NMOSD) attack by 77% compared to placebo in patients with NMOSD.