BMS, Endo, Merck & Co., and Sanofi Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from BMS, Endo, Merck & Co., and Sanofi.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday February 1, 2017 to Tuesday February 7, 2017.
FDA OKs Bladder Cancer Indication for BMS’ Cancer Drug
Bristol-Myers Squibb (BMS) has received approval from the US Food and Drug Administration for Opdivo (nivolumab) injection for treating locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. This specific indication is for use in patients who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The FDA granted this application priority review and previously granted breakthrough therapy designation to Opdivo for this indication.
In the US, Opdivo is indicated for treating patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, BRAF V600 wild-type unresectable or metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic urothelial carcinoma. In addition, Opdivo is indicated in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma.
Opdivo had 2016 sales of approximately $3.8 billion.
Source: Bristol-Myers Squibb
Endo Gets FDA OK for Hypotension Drug
Par Pharmaceutical, a subsidiary of Endo International, has received final approval from the US Food and Drug Administration for its new drug application for ephedrine sulfate injection, a drug administered parenterally as a pressor agent for treating hypotension in surgical settings. Par expects to start shipping the product in February 2017.
US sales of ephedrine sulfate injection products were approximately $177 million for the 12 months ended November 30, 2016, according to QuintlesIMS Health data and as cited by Endo.
Source: Endo International
EC OKs New Lung Cancer Indication for Merck & Co.’s Anti-Cancer Agent
Merck & Co. has received approval from the European Commission (EC) for a new lung cancer indication for Keytruda (pembrolizumab), the company’s anti-programmed death-1 therapy. The EC approved Ketrudua for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no epidermal growth factor receptor or anaplastic lymphoma kinase-positive tumor mutations.
In related news, the US Food and Drug Administration accepted two supplemental biologics applications (sBLAs) for Keytruda (pembrolizumab) from Merck this month. The sBLAs were filed for use in patients with locally advanced or metastatic urothelial cancer. In the US, Keytruda is indicated for treating melanoma, lung cancer, and head and neck cancer. The drug had 2016 sales of $1.4 billion.
Source: Merck & Co.
Canada OKs Sanofi’s RA Drug
Sanofi and Regeneron Pharmaceuticals have received approval from Health Canada for Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating moderately to severely active rheumatoid arthritis. Kevzara will be marketed by Sanofi Genzyme, the specialty care global business unit of Sanofi.
In addition, the companies expect to resubmit a biologics license application for sarilumab with the US Food and Drug Administration (FDA) in the first quarter of 2017. This resubmission is subject to the completion of an inspection by the FDA of Sanofi’s fill and finish facility in Le Trait, France, with an anticipated action date in the second quarter.
In Europe, the European Medicines Agency accepted for review the marketing authorization application for sarilumab in July 2016, and a decision is expected later this year.
FDA OKs Sanofi’s Allergy Med as OTC
Sanofi has received approval from the US Food and Drug Administration for Xyzal (levocetirizine dihydrochloride) Allergy 24HR product for the over-the-counter (OTC) treatment of seasonal and year-round allergies.
Specifically, two formulations of Xyzal are now approved for OTC use: 5 mg tablets for ages 6 years and older and 0.5 mg/mL oral solution for ages 2 years and older. Xyzal is an oral antihistamine that has a 24-hour effect.