Top Blockbuster Drugs for 2019

Christopher Peterson, PharmD

Aimee Tharaldson, PharmD

Major blockbuster drugs slated for launch in 2019 are expected to have a significant impact on treating certain cancers, diabetes, peanut allergies, and other conditions.

Many medication launches will treat a variety of cancers, says Christopher Peterson, PharmD, director of Emerging Therapeutics for Express Scripts. “Cancer therapies represent about one-third of all specialty drugs in the pipeline, so a significant number of cancer drug approvals is expected into the future,” he says.

Cancer drugs

Sacituzumab govitecan (Immunomedics), a novel, first-in-class antibody-drug conjugate (ADC) for treating breast cancer, was granted priority review by the FDA in July 2018. It is one of the top cancer medications expected to receive FDA approval in early 2019, according to Aimee Tharaldson, PharmD, senior pharmacist with Emerging Therapeutics at Express Scripts.

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Tagraxofusp (Elzonris, Stemline Therapeutics), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer, is also expected to receive final approval in February.

Other expected major cancer drug launches include oral selinexor (Karyopharm Therapeutics) to treat multiple myeloma and oral erdafitinib (Janssen), which received breakthrough therapy designation in March 2018, for urothelial cancer.

LOXO-292 (Loxo Oncology), received breakthrough designation from the FDA for patients with metastatic RET-fusion-positive non-small cell lung cancer (NSCLC) as well as a last-line treatment of RET-positive thyroid cancer, is another cancer therapy to watch, says John Santilli, president of Market Access Intelligence.

In the lucrative diabetes drug market, semaglutide (Ozempic, Novo Nordisk), a GLP-1 agonist for type 2 diabetes approved in 2018, may achieve blockbuster status in 2019, Santilli said. “Ozempic has been gaining market share during this year in Canada and Denmark, in addition to the United States.”

Another potentially big diabetes drug, sotagliflozin (Zynquista, Lexicon), has a PDUFA date of March 22, 2019. The oral dual inhibitor of SGLT-1 and SGLT-2 is used in combination with insulin to improve blood sugar control in patients with type 1 diabetes, Peterson says.

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Inflammatory conditions

The projected big new drugs for inflammatory conditions in 2019 include upadacitinib (AbbVie) for rheumatoid arthritis and risankizumab (Boehringer Ingelheim and AbbVie) for psoriatic arthritis, Crohn’s disease, and other inflammatory conditions, according to Tharaldson.

Viaskin Peanut (DBV Technologies), which has a PDUFA date of June 22, 2019, is a novel allergy immunothearpy, administered daily via transdermal patch for desensitizing pediatric patients with peanut allergies. “Around three out of 500 patients in the United States have an allergy to peanuts,” Tharaldson said. “This could be a blockbuster medication.”

Another potential blockbuster drug is esketamine (Ketanest, Janssen) nasal spray, which received breakthrough designation and is expected to be approved by FDA in early May 2019. Esketamine treats major depressive disorder, which affects around 16 million Americans, with imminent risk for suicide. “In a clinical trial, within 3 days, more than 60% of patients receiving esketamine saw improvement in depressive symptoms,” Tharaldson said.

HIV

In the HIV market, bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy, Gilead Sciences), launched in 2018, will “continue to provide strong growth for the company in 2019 on its way to becoming a blockbuster drug,” Santilli says. “This HIV ‘triplet’ medicine, combining different treatments into a single formulation, recently demonstrated high efficacy, high barrier to resistance, and long-term tolerability, re-affirming the drug as a first-line treatment option for suitable adult HIV patients who are starting therapy.”

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