Sanofi, Merck & Co. Inc. Lead Drug Approval NewsBy
A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news, with news from Sanofi.b>
Editor’s note: This article was updated on a continuous basis from news announced from Wednesday May 17 to Tuesday May 23, 2017.
Sanofi Receives FDA OK for Rheumatoid Arthritis Drug
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have received US Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for treating adults with moderately to severely active rheumatoid arthritis (RA). The drug is specifically approved for those patients who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs, such as methotrexate.
Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling, according to information by the companies. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with RA.
In the US, Kevzara will be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi. Kevzara was approved in Canada in January 2017. In April 2017, the European Medicine Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for the marketing authorization of Kevzara, recommending its approval for use in adult patients with moderately to severely active RA. A final decision on the marketing authorization application for Kevzara in the European Union will be made by the European Commission in the coming months. The companies are also seeking approvals in a number of other countries globally.
FDA OKs Two New Bladde Cancer Indications for Merck & Co.’s Immuno-Oncology Drug Keytruda
The US Food and Drug Administration (FDA) has approved two new indications for Merck & Co.’s immuno-oncology drug, Keytruda (pembrolizumab), an anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Keytruda is one of Merck’s top-selling drugs with 2016 sales of $1.4 billion.
The drug is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Keytruda is also now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The drug is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Keytruda is also approved in the US for treating unresectable or metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, and refractory classical Hodgkin lymphoma.
Source: Merck & Co. Inc.