Merck & Co., AstraZeneca, and Roche Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche, Merck & Co., AstraZeneca, and Shire.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday January 10, 2018 date to Tuesday January 16, 2018.
EC OKs Roche’s Multiple Sclerosis Drug Ocrevus
The European Commission has granted approval for Roche’s Ocrevus (ocrelizumab) for certain types of multiple sclerosis.
The drug was approved for patients with active relapsing-remitting multiple sclerosis confirmed by imaging or clinical findings and in patients with early primary progressive multiple sclerosis, which takes into account disease duration, degree of disability, and imaging findings indicative of inflammatory activity.
Ocrevus is already approved in various countries in North America, South America, the Middle East, Eastern Europe, Australia, and Switzerland.
Ocrevus is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to the damage of myelin and axonal nerve cells.
FDA OKs New Use for Merck & Co.’s, AstraZeneca’s Breast Cancer Drug Lynparza
The US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s and Merck & Co.’s Lynparza (olaparib) for use in patients with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
This is the third indication approved for Lynparza in the US; it is also approved for treating advanced ovarian cancer. The drug is being studied in other cancers, including breast, ovarian, prostate, and pancreatic cancers.
Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor and the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells, according to information from the companies and the FDA.
In July 2017, AstraZeneca and Merck & Co., entered into a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza for multiple cancer types. The companies are jointly developing Lynparza and selumetinib, the active ingredient in another AstraZeneca cancer drug, in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop Lynparza and selumetinib in combination with their respective programmed death-ligand 1 (PD-L1) and PD-1 medicines.
EC Grants Shire Approval for Hemophilia A Drug Adynovi
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [antihemophilic factor (recombinant), PEGylated], an extended half-life recombinant factor VIII treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
Shire says Adynovi is modified to last longer in the blood and potentially require less frequent injections than unmodified antihemophilic factor when used to reduce the frequency of bleeding. It is built on Advate [antihemophilic factor (recombinant)], a treatment used by hemophilia A patients.
With this approval, Shire is now authorized to market Adynovi in the 28 member states of the European Union as well as in Iceland, Liechtenstein, and Norway.
Adynovi was first approved as Adynovate [antihemophilic factor (recombinant), PEGylated] by the US Food and Drug Administration followed by approval in Japan, Canada, and Colombia and is approved as Adynovi in Switzerland. Adynovate most recently received approval in Japan for use in hemophilia A pediatric patients under 12 years of age and those undergoing surgery in November 2017.