Radar on Specialty Pharmacy

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk myelodysplastic syndromes. The agency gave the application priority review and orphan drug designation. Review of the application was done in collaboration with agency counterparts in Canada and Australia through Project Orbis (RSP 10/19, p. 12). Dosing is one tablet once daily on days one through five of each 28-day cycle. Taiho Oncology will commercialize the drug in the U.S. Its launch is pending. Visit www.inqovi.com.

✦ July 9: The FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations. Dosing varies depending on the indication. A patent license agreement with AbbVie will allow the drug to launch in the U.S. in 2023. Visit https://bit.ly/2DnyjOZ.

Chronic kidney disease (CKD) affects almost 40 million people in the United States. The condition can cause a variety of health complications, including anemia. Treatments for anemia of CKD consist of erythropoiesis-stimulating agents (ESAs), the first of which the FDA approved in 1989. But a new kind of drug is poised to shake up the class, with the first expected approval potentially happening later this year.

When people’s kidneys are healthy, they produce erythropoietin, a product that prompts the bone marrow to make red blood cells. When the kidneys are damaged, their erythropoietin production goes down, causing a decline in red blood cells, which in turn causes anemia.

AstraZeneca and Merck & Co., Inc. released positive results of Lynparza’s Phase III PROfound trial last August. Shortly thereafter, from Sept. 3, 2019, to Oct. 7, 2019, Zitter Insights polled 51 commercial payers with 158.4 million covered lives about how they were likely to manage the therapy.

Commercial payers with 60% of covered lives said they were more likely than unlikely and significantly likely to manage Lynparza at parity with other drugs in the second-line treatment of metastatic castration- resistant prostate cancer (see chart below). The same percentage of payers said they were neither likely nor unlikely to cover it over all other therapies.

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate). Lynparza also has approvals in breast, ovarian and pancreatic cancers.

A recent court decision put Mylan N.V. in the spotlight for its win over Biogen concerning the patent of the latter’s best-selling multiple sclerosis (MS) therapy Tecfidera (dimethyl fumarate). The decision to invalidate the patent paves the way for Mylan to launch a generic of the drug this fall, assuming the FDA approves it. But seemingly under the radar is another manufacturer’s announcement that it would launch a generic novel fumarate next month, possibly making it the first on the U.S. market.

The FDA approved Banner Life Sciences LLC’s Bafiertam (monomethyl fumarate) on April 28 for the treatment of adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The drug was approved through a new drug application under the 505(b)(2) pathway, with Tecfidera as the reference drug.