The pipeline outlook for 2020 is strong, with over 150 drugs that could be approved by the FDA in the next year, according to an OptumRx report.
OptumRx’s Pipeline Drug Surveillance team monitors over 1000 new drugs and indications at any given time. The report, which is released quarterly, highlights the most notable drugs being reviewed by the FDA.
Among the most anticipated drugs in the pipeline is bempedoic acid, according to the report. If approved, this new treatment will represent a new class of drugs for high cholesterol.
“Since bempedoic acid is taken by mouth, we believe it will be favored over injectables like [proprotein convertase subtilisin/kexin type 9] inhibitors, a biologic drug that significantly lowers LDL-C levels,” the report indicated. However, since there are many drugs available for the management of high cholesterol, bempedoic acid will likely to be used as a second- or third-line option, according to the report.
The first oral immunotherapy drug, AR-101, for peanut allergy was also highlighted. In a clinical trial, AR-101 reduced allergic reactions from exposure to peanuts, but did exhibit limitations such as an approximately 6 month dose escalation period. AR-101 was also associated with a higher discontinuation rate due to adverse events and a higher rate of epinephrine use.
“However, the results of the pivotal trial demonstrate that AR-101 could substantially change the outlook for many patients who have a peanut allergy by potentially reducing the risk of severe allergic reactions from accidental peanut exposure,” the report said.
A large population of patients are affected by peanut allergy; however, there are limited treatment options. Viaskin Peanut, which is being developed by DBV Technologies, is another investigational immunotherapy being reviewed by the FDA with a target action date of August 2020.
Obeticholic acid is also a highly-anticipated drug listed in the report, as it would be the first treatment for nonalcoholic steatohepatitis (NASH). The drug is already on the market for primary biliary cirrhosis, but has not yet been approved for NASH. Approval is expected in 2020 based on positive results from the REGENERATE phase 3 study showing obeticholic acid improved liver fibrosis without worsening NASH at 18 months. However, the proportion of patients experiencing resolution of NASH was no different from placebo, the report noted.
“Given the large (and growing) target population in conjunction with the high unmet treatment need, it is projected that pricing for obeticholic acid for NASH will be between $10,000 to $18,000 per patient per year,” the report said.
- OptumRx. OptumRx Drug Pipeline Insights Report Q1 2020. 2020. https://www.optum.com/content/dam/optum3/optum/en/resources/PDFs/OptumRx_Q1_2020%20PipelineInsightsReport.pdf. Accessed January 29, 2020.