|Bristol-Myers Receives Positive CHMP Opinion for Daklinza; FDA Statement Regarding Afrezza|
|By Staff and Wire Reports|
|Friday, 27 June 2014 20:11|
Bristol-Myers Squibb Company (NYSE: BMY) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza® (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
“Through Bristol-Myers Squibb's Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir,” said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. “We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.”
Recently included in the European Association for the Study of the Liver's (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gone through an accelerated review process. The positive CHMP opinion was based on data from multiple studies of Daklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.
Applications for Daklinza-based regimens are also pending in Japan and the U.S. A decision from Japan's Pharmaceutical and Medical Devices Agency is expected soon, and the U.S. Food and Drug Administration has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.
Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuations across a range of patients.
Afrezza has a Boxed Warning advising acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.
The FDA is requiring the following post-marketing studies for Afrezza:
•a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients;
•a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function);
•two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability.
Amedisys, Inc. (Nasdaq:AMED), one of America's leading home health and hospice care companies, today announced its expectations for certain financial results for the second quarter ending June 30, 2014.
BioCorRx, Inc. (OTCQB: BICX), a leader in addiction treatment and rehabilitation programs, announced it has closed the sale for the exclusive license and distribution rights of its Start Fresh Program to multiple wholly owned subsidiaries of Start Fresh Midwest Holdings, LLC, which consist of common majority owners of Fresh Start Private Midwest, LLC.
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP's manufacturing site with no findings nor issuance of Form 483 observations.
iKang Healthcare Group, Inc. (Nasdaq:KANG), the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, announced today it will attend the Citi Healthcare Corporate Day 2014 to be held on July 8th at Island Shangri-la Hotel, Pacific Place, Supreme Court Road, Central, Hong Kong.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, announced that it will be added to the Russell 3000® and Russell 2000® Indexes, Friday, June 27, 2014, when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes.
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) today announced the pricing of its underwritten public offering of 2,647,247 shares of its common stock at a price of $42.50 per share before underwriting discounts.
MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food & Drug Administration (FDA) has approved AFREZZA® (insulin human) Inhalation Powder to improve glycemic control in adult patients with diabetes mellitus.
Prosensa Holding N.V. (NASDAQ: RNA), the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today announced that Dr. Judith van Deutekom, Prosensa's Vice President of Drug Discovery, has been awarded a $200,000 research grant from Parent Project Muscular Dystrophy (PPMD), the largest non-profit organization in the United States focused on finding a cure for Duchenne Muscular Dystrophy (DMD), to fund the development of a multi exon-skipping strategy for exons 10-30 of the dystrophin gene.
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that new clinical data on ELELYSOTM (taliglucerase alfa) will be presented at the European Working Group on Gaucher Disease 2014 11th Meeting being held June 25-28 in Haifa, Israel.
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that three oral presentations detailing the final results from the rolapitant registration program were delivered today at the MASCC/ISOO International Symposium on Supportive Care in Cancer annual meeting in Miami.
Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced the appointment of Frank Thomas to the Company's Board of Directors. In this new role he will also serve as the Chair of the Audit Committee.