Lilly, Bayer, J&J, and Merck & Co. Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Lilly, Johnson&Johnson, and Merck & Co.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, December 6, 2017 to Tuesday, December 12, 2017.

FDA Accepts Lilly’s BLA for Migraine Drug
The US Food and Drug Administration (FDA) has accepted Eli Lilly and Company’s biologics license application (BLA) for galcanezumab for preventing migraine in adults.

Galcanezumab has been submitted for use as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.

Galcanezumab represents the first of three investigational, non-opioid treatments in development as part of Lilly’s overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for treating osteoarthritis, chronic low back pain, and cancer pain.

Source: Eli Lilly and Company


Bayer, J&J Submit sNDA for New Use of Anticoagulant Xarelto
Bayer and Janssen Research & Development, part of Johnson & Johnson, have submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for two new vascular indications for Xarelto (rivaroxaban), an anticoagulant. These indications are for reducing the risk of major cardiovascular (CV) events such as CV death, heart attack, or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of acute limb ischemia in patients with PAD.

Xarelto is approved for seven indications, including preventing: (1) stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors; (2) pulmonary embolism (PE) in adults; (3) deep vein thrombosis (DVT) in adults; (4) recurrent PE and DVT in adults; (5) venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery; (6) VTE in adult patients undergoing elective knee replacement surgery; and (7) atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after acute coronary syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.

Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development. Xarelto is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals (Janssen Research & Development and Janssen Pharmaceuticals are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).

Source: Johnson & Johnson and Bayer


FDA Gives Merck & Co. Priority Review for New Use of Cancer Drug Keytruda
The US Food and Drug Administration (FDA) has accepted Merck & Co.’s supplemental biologics license application (sBLA) for its cancer drug, Keytruda (pembrolizumab), for treating adult and pediatric patients with refractory primary mediastinal B-cell lymphoma or who have relapsed after two or more prior lines of therapy.

The FDA granted priority review status with a Prescription Drug User Fee Act, or target action date of April 3, 2018. In January 2017, Keytruda was granted breakthrough therapy designation by the FDA for this indication.

Keytruda is indicated for treating various cancers: unresectable or metastatic melanoma; locally advanced or metastatic urothelial carcinoma, head and neck cancer, classical Hodgkin lymphoma, certain forms of gastric cancer, and microsatellite instability-high cancer.

Source: Merck & Co.

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