AbbVie, Merck & Co., Pfizer, and Teva Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, Merck & Co., Perrigo, Pfizer, and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday February 1, 2017 to Tuesday February 7, 2017.
FDA Gives Priority Review to AbbVie’s Hep C Combo Regimen
The US Food and Drug Administration has accepted and granted priority review to AbbVie’s new drug application for G/P (glecaprevir/pibrentasvir), an investigational, pan-genotypic regimen for treating all major genotypes (GT1-6) of chronic hepatitis C virus (HCV).
G/P is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment. AbbVie is also studying G/P in patients with specific treatment challenges, such as GT3 patients who were not cured with previous direct-acting antiviral treatment and those with chronic kidney disease, including patients on dialysis.
G/P combines two antiviral agents in a fixed-dose combination of glecaprevir (100mg), a nonstructural protein (NS) 3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor. Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals, a Watertown, Massachusetts-based biotechnology company, for HCV protease inhibitors and regimens that include protease inhibitors.
In January 2017, AbbVie’s marketing authorization application with the European Medicines Agency for G/P was validated and placed under accelerated assessment by the agency.
FDA Accepts Merck & Co.’s Supplemental Filings for Cancer Drug
Merck & Co.’s two supplemental biologics applications (sBLAs) for Keytruda (pembrolizumab), the company’s anti-programmed death (PD)-1 therapy for cancers, have been accepted for review by the US Food and Drug Administration (FDA). The sBLAs were filed for use in patients with locally advanced or metastatic urothelial cancer.
One sBLA, which was submitted for first-line use, has been granted priority review for treating patients who are ineligible for cisplatin-containing therapy. The second sBLA, submitted for second-line use, has been granted priority review for patients with disease progression on or after platinum-containing chemotherapy. The Prescription Drug User Free Act, or target action, date for both applications is June 14, 2017.
The FDA previously granted breakthrough therapy designation to Keytruda for the second-line treatment of patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy.
In the US, Keytruda is indicated for treating melanoma, lung cancer, and head and neck cancer. The drug, which had been previously pegged by some analysts as a blockbuster, earned 2016 sales of $1.4 billion.
Keytruda was also recently approved for a new lung cancer indication by the European Commission in January 2017.
Source: Merck & Co.
Perrigo Files Application for Generic Acne Drug
Perrigo has filed an abbreviated new drug application with the US Food and Drug Administration (FDA) for clindamycin, benzoyl peroxide topical gel, the generic version of Valeant Pharmaceuticals’ Onexton gel (clindamycin phosphate 1.2%; benzoyl peroxide 3.75%).
Perrigo has notified Valeant Pharmaceuticals North America and Dow Pharmaceutical Sciences (Valeant) of its filing. Valeant owns both the new drug application and patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), which identifies drug products approved on the basis of safety and effectiveness by the FDA.
Onexton gel (clindamycin phosphate 1.2%; benzoyl peroxide 3.75%) is a prescription medicine indicated for treating comedonal (non-inflammatory) and inflammatory acne. Branded sales for the 12 months ending December 2016 were approximately $139 million, according to Perrigo.
Pfizer’s Submission of ADC Accepted by FDA and EMA
Pfizer’s biologics license application (BLA) to the US Food and Drug Administration (FDA) and marketing authorization application (MMA) to the European Medicines Agency (EMA) have been accepted for Mylotarg (gemtuzumab ozogamicin), an antibody drug conjugate for treating acute myeloid leukemia (AML), according to Pfizer in its 2016 fourth quarter and full-year earnings report.
The FDA accepted the BLA filing in January 2017 and the EMA accepted the MMA filing in December 2016.
Mylotarg was originally approved by the FDA in 2000 under an accelerated approval program for use as a single agent in first relapse patients with CD33-positive AML who were 60 years or older. In 2010, Pfizer voluntarily withdrew Mylotarg after a confirmatory Phase III trial at that time did not show a clinical benefit, and the fatal induction toxicity rate was significantly higher in the Mylotarg arm.
The recent applications are resubmissions of Mylotarg that include additional data from a recent Phase III clinical study that evaluated the addition of Mylotarg to standard induction chemotherapy. The Prescription Drug User Free Act goal date for a decision by the FDA is in September 2017.
Mylotarg originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule
Teva Files Generic Version of Novo Nordisk’s Diabetes Drug
Teva Pharmaceutical Industries has filed an abbreviated new drug application with the US Food and Drug Administration seeking approval to market a generic version of Novo Nordisk’s Victoza (liraglutide) injection, an anti-diabetes drug. Should Teva’s application be approved, Teva may be entitled to 180 days of generic market exclusivity.
Victoza is one of Novo Nordisk’s top-selling drugs, with 2016 sales of Danish krone $20 billion ($2.9 billion). In the US, Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
Source: Teva Pharmaceutical Industries