AbbVie, GSK, Merck & Co., and Novo Nordisk Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, GlaxoSmithKline, Merck & Co., and Novo Nordisk. 

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 30, 2016 to Tuesday December 6, 2016.

AbbVie Gets Orphan Drug Status for Crohn’s Disease Drug
AbbVie has been granted orphan drug designation by the US Food and Drug Administration for risankizumab, an investigational treatment for Crohn’s disease in pediatric patients. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialization of the compound globally.

Risankizumab is being evaluated in immunological disorders, including Crohn’s disease, psoriasis, psoriatic arthritis, and asthma. Risankizumab is not currently approved by regulatory authorities, according to AbbVie.

The FDA orphan drug designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.

Source: AbbVie


FDA Fast Tracks Daiichi Sankyo’s Breast Cancer Drug
The US Food and Drug Administration has granted fast track designation to Daiichi Sankyo Company for its investigational HER2-targeting antibody drug conjugate (ADC), DS-8201. The ADC is being developed for treating HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine.

DS-8201 is currently in Phase I clinical development for HER2+ advanced or metastatic breast cancer or gastric cancer, HER2 low-expressing breast cancer, and other HER2-expressing solid cancers. It is comprised of a humanized anti-HER2 antibody attached by a peptide linker to a topoisomerase I inhibitor that utilizes Daiichi Sankyo’s proprietary linker-payload technology.

Source: Daiichi Sankyo 


GSK Seeks EMA Approval for Respiratory Triple Combo Drug
GlaxoSmithKline (GSK), with its partner Innoviva, a Brisbane, California-based pharmaceutical company, has filed a regulatory submission with the European Medicines Agency for an once-daily, closed triple combination therapy, FF/UMEC/VI 100/62.5/25 mcg (fluticasone furoate/umeclidinium/vilanterol), for treating chronic obstructive pulmonary disease (COPD). This follows the announcement of the submission of a new drug application for FF/UMEC/VI in the US in November 2016.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist. The combination therapy is delivered once-daily in GSK’s Ellipta dry-powder inhaler.

The European Union regulatory submission of closed triple therapy comprises a marketing authorization application for a maintenance treatment to relieve symptoms of adult patients with COPD. Regulatory submissions of closed triple therapy for COPD are anticipated in the rest of the world beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world, according to GSK.

Source: GlaxoSmithKline 


FDA OKs Priority Review for Merck’s Keytruda in Hodgkin’s Lymphoma
The US Food and Drug Administration (FDA)has granted priority review to Merck & Co. for the company’s supplemental biologics license application for Keytruda (pembrolizumab), Merck’s anti-programmed death-1 anticancer therapy, seeking a new indication in treating patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy.

This follows an earlier decision by the FDA in November 2016 granting Keytruda a breakthrough status designation for treating previously treated patients with advanced microsatellite instability-high cancer.

The priority review status in the refractory cHL indication has a Prescription Drug User Fee Act, or target action, date of March 15, 2017. In April 2016, Keytruda was granted breakthrough therapy designation by the FDA for this indication. The application is seeking approval for Keytruda at a fixed dose of 200 mg administered intravenously every three weeks.

In the US, Keytruda is indicated for melanoma, lung cancer, and head and neck cancer. The drug is positioned as a potential blockbuster for Merck with projected sales of $3.5 billion in 2019, according to a Thomson Reuters analysis

Source: Merck & Co.


Novo Nordisk Seeks US, EU Approval for Diabetes Therapy
Novo Nordisk has submitted a new drug application to the US Food and Drug Administration and a marketing authorizations application to the European Medicines Agency for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue for treating adults with Type 2 diabetes.

Semaglutide is a once-weekly analogue of human GLP-1 that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, while decreasing appetite and food intake. Novo Nordisk intends to make once-weekly semaglutide available in a prefilled delivery device based on the same technology platform as its FlexTouch injection pen.

Source: Novo Nordisk


FDA Accepts Submission to Expand Abilify Label
Otsuka Pharmaceutical and its partner H. Lundbeck, a New York-based pharmaceutical company, have received notification from the US Food and Drug Administration (FDA) that the supplemental new drug application for expanded labeling of the anti-psychotic drug, Abilify Maintena (ariprazole), has been accepted for review. Otsuka is seeking expanded labeling for Abilify Maintena to be used for maintenance treatment of bipolar I disorder in adult patients. Under the Prescription Drug User Fee Act, the FDA has set a target date of July 28, 2017, to complete its review.

Abilify Maintena is an extended-release injectable suspension version of Abilify, an atypical anti-psychotic, for intramuscular use. Abilify Maintena was developed by Otsuka in Japan and is co-commercialized by the alliance between Otsuka and H. Lundbeck. The drug was approved in the US in 2013 for the treatment of adults with schizophrenia.

Source: Otsuka Pharmaceutical 

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