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Here are the top drugs expected to be approved this year and their financial impact.
According to the FDA, 38 drugs have been approved in 2019 as of November 15, 2019, bringing more treatment options to the market for patients. Vizient, a healthcare performance improvement company, released its 2019 Drug Price Forecast for health systems, with an expected 4.57% increase for pharmaceutical purchases made from January 1, 2020 to December 31, 2020.
Here are drugs in the pipeline expected to be approved in 2020 and their financial impact.
Pipeline drugs for 2020
It can sometimes be difficult to predict which medications will be approved, as there can be drug safety issues that the FDA needs more clarification on and further studies may be warranted, says Erin Fox, PharmD, BCPS, FASHP, senior director, Drug Information and Support Services, University of Utah Health, Salt Lake City. Fox provides budget forecasting in her clinical practice setting and discussed that the budget is generally set after drugs receive FDA approval.
According to Fox, the pharmacy and therapeutics committee reviews the medications, and drug monographs are created to determine whether the new drugs will be added to the hospital formulary. The FDA approved Eli Lilly’s Reyvow (lasmiditan) for acute treatment of migraine with or without aura, and it is expected to be available in January 2020. Reyvow is unique in that it is the first FDA-approved medication in a new class of acute migraine treatments known as serotonin (5-HT)1F receptor agonists.
Adakveo (crizanlizumab-tmca) received FDA approval November 15, 2019, which is two months ahead of schedule. Adakveo is manufactured by Novartis and is the first targeted therapy to treat patients with sickle cell pain. Additionally, Adakveo received orphan drug designation, which provides incentives to the manufacturer. Alder Biopharmaceuticals submitted the Biologics License Application (BLA) for eptinezumab for migraine prevention, and the expected approval date is February 21, 2020. Eptinezumab is a monocloncal antibody that has demonstrated positive results for migraine prevention in the PROMISE 1 and PROMISE 2 phase 3 studies. Seattle Genetics and Astellas have submitted the BLA for enfortumab vedotin for advanced or metastatic bladder cancer, and the target approval date is March 15, 2020. Enfortumab vedotin is considered a novel investigational antibody-drug conjugate that targets Nectin-4, which is a protein that is prevalent in bladder cancer. The BLA submission was based on positive results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial.
Merck received FDA approval December 19, 2019 for Ervebo, the first FDA approved vaccine for the prevention of Ebola virus disease. Biohaven Pharmaceuticals is studying rimegepant for acute treatment and prevention of migraine. Rimegepant is a calcitonin gene-related peptide receptor antagonist with a long half-life and good oral bioavailability, and the New Drug Application (NDA) has been submitted to the FDA with an expected approval of early 2020. Data presented at the International Headache Conference demonstrated that rimegepant decreased disability by about 41% and reduced lost productivity time by approximately 50% over a one-year treatment period.
Alnylam Pharmaceutical’sGivlaari (givosiran) was approved November 20, 2019, earlier than the expected date of February 4, 2020, for the treatment of acute hepatic porphyria, a rare genetic disease that can resemble other conditions and affect quality of life. Givlaari is the first drug approved for this rare disease, and it comes with a high wholesale price of $575,000. Alnylam plans to offer patient assistance and work with insurance companies to help provide coverage. The ENVISION phase 3 study demonstrated that Givlaari improved quality of life measures compared to placebo.
Epizyme’s tazemetostat was granted priority review for patients with epithelioid sarcoma who cannot receive curative surgery, and approval is expected January 2020. Additionally, Epizyme’s marketing and education strategies are in place in anticipation of tazemetostat’s approval.
Intercept has submitted an NDA for obeticholic acid for patients with fibrosis due to nonalcoholic steatohepatitis (NASH), a type of liver disease. 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.
Jennifer Gershman, PharmD, CPh, is a pharmacist and medical writer residing in South Florida.