A new class of drugs for high cholesterol and a novel peanut allergy treatment lead expected approvals.
A new class of drugs for high cholesterol are among the top 3 drugs that are expected to be approved in the first half of 2020, according to PBM OptumRx.
In its new Q1 2020 Drug Pipeline Insights Report, OptumRx highlights 3 treatments nearing their anticipated approval date in the first half of 2020 that will have the biggest impact on payers and patients. Here are the top 3:
1. Bempedoic acid (Esperion Therapeutics) will be the first in a new class of drugs to treat high cholesterol. It works differently by inhibiting an enzyme [ATP-citrate lyase] involved in cholesterol production and can be taken in combination with other lipid-lowering therapies for patients who may not be at their goal with existing therapy.
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"More than 37% of Americans have elevated low-density lipoprotein-cholesterol (LDL-C), more commonly known as high cholesterol…Additionally, 18 million individuals with atherosclerotic cardiovascular disease have elevated LDL-C levels despite treatment with currently available therapies, highlighting the need for new approaches when the condition is unmanaged,” Sumit Dutta, chief medical officer at OptumRx wrote in the report.
In clinical trials, bempedoic acid lowered LDL-C by approximately 15% to 30%, compared to placebo.
“Since bempedoic acid is taken by mouth, we believe it will be favored over injectables like PCSK9 inhibitors, a biologic drug that significantly lowers LDL-C levels,” Dutta wrote.
2. AR-101 (Palforzia, Aimmune Therapeutics), approved by FDA late last week, is the first oral immunotherapy to reduce allergic reactions from exposure to peanuts. It is ingested to gradually increase doses of purified peanut protein, in order to help the immune system learn to tolerate peanuts.
“Current care for peanut allergy is to strictly avoid peanuts and, in cases of accidental exposure, use epinephrine injections. Because of the large patient population, and minimal treatment options, there is a $4.5 billion global market for drug manufacturers to treat peanut allergies,” Dutta wrote.
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In one clinical trial, approximately two thirds of patients taking AR-101 were able to ingest a dose of 600 mg. (approximately two peanut kernels) or more of peanut protein without symptoms (e.g., moderate to severe allergic reactions), vs. 4% of patients treated with the placebo.
However, the drug has some limitations and Aimmune predicted it would cost $6,000 to $8,000 for the six-month dosing-up phase and $4,000 to $5,000 for a year of maintenance, according to OptumRx.
3. If approved, obeticholic acid (Intercept Pharmaceuticals) would be the first treatment for nonalcoholic steatohepatitis (NASH), a liver condition affecting 16 million American adults.
The treatment will also likely be an attractive option for patients struggling to lose weight, Dutta wrote.
Obeticholic acid is on the market already, available under the brand name Ocaliva for a rare liver disease called primary biliary cirrhosis, but it has not yet been approved for the treatment of NASH.
“Because this condition has direct ties to obesity, NASH prevalence is rising and is an increasing contributor to growing liver-related morbidity and mortality statistics. At its current rate of growth, NASH is projected to become the leading indication for liver transplantation in the U.S. in 2020,” Dutta wrote.
“Given the large (and growing) target patient 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,” he added.
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