FDA approves Lilly’s breast cancer drug Verzenio
SILVER SPRING, Md. — Eli Lilly’s new treatment for certain breast cancers has been approved by the Food and Drug Administration. Verzenio (abemaciclib) was approved to as a treatment for patients with a hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is advanced or metastatic and has progressed following endocrine therapy.
"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a standalone treatment to patients who were previously treated with endocrine therapy and chemotherapy," said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Verzenio works by blocking certain molecules that are involved in cancer cell growth. It joins two previously approved drugs in this class — palbociclib (Pfizer’s Ibrance) and ribociclib (Novartis’ Kisqali). The National Cancer Institute and the National Institutes of Health estimate that roughly 252,710 people will be diagnosed with breast cancer this year. Approximately 72% of patients have breast cancer with tumors that fit the criteria for treatment with drugs like Verzenio.
NCPA-commissioned study: DIR fees could cost CMS $3.4B in next 10 years
ALEXANDRIA, Va. — Retroactive pharmacy payment reductions, a portion of direct and indirect remuneration fees, could cost the federal government $3.4 billion between 2018 and 2027. That’s according to a new study from Wakely Consulting Firm that the National Community Pharmacists Association commissioned and whose results it shared Thursday.
“This new Wakely study is vitally important in showing that DIR legislation will actually save taxpayers $3.4 billion over 10 years without subtracting any benefits seniors currently receive,” NCPA CEO Doug Hoey said. “For pharmacies, banning these after-the-fact fees is the fair way to achieve predictability in the reimbursement for the medications they buy and dispense.”
The report evaluates the impact of the Improving Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, which has been introduced in both the Senate and House of Representatives and prohibits retroactive pharmacy payment reductions as claims without any defect, impropriety or fraud in Medicare Part D.
If the legislation were enacted, it would save the Centers for Medicare and Medicaid service from spending that $3.4 billion over the coming 10 years. The report also notes that CMS would spend less on federal reinsurance and low-income cost-sharing subsidies. Under the legislation, the decrease in total drug cost at point of sale would lower the number of claim dollars in the catastrophic phase of the Part D benefit, the report said. The legislation is part of NCPA’s efforts to end DIR Fees, which make up a small amount of overall DIR within Medicare Part D, the majority of which is made up of manufacturer rebates, and Hoey said the results underscore the need for a legislative answer to the issue.
“This new Wakely study is robust in its scope and thoroughness and points clearly to significant cost savings to the federal government if H.R. 1038/S.413 were passed into law,” said Hoey. “We urge Congress to move quickly to schedule hearings and advance this important legislation.”
FDA approves first generic from Vitruvias Therapeutics, Sunny Pharmtech
SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic from Taiwan-based drug development company Sunny Pharmtech and generic development company Vitruvias Therapeutics. The companies announced the approval of its generic lidocaine ointment, 5%.
“We are pleased to have received such a timely approval with our first jointly filed application,” Sunny Pharmtech CEO and chairperson Yon-Lian Wu said. “It is a testament to competence and capabilities of both companies’ development and regulatory groups that our first application was approved so quickly.”
The generic is the first drug approved under the two companies’ joint development agreement that includes eight products.
“It is very exciting to receive our first joint approval, and we are looking forward to beginning the commercial phase of our business plan,” Vitruvias GM Carl Whatley said. “This approval represents our transition from a purely developmental company to one that can discover, develop and commercialize technically complex generics."