A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, Roche, and Cel-Sci.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday September 28, 2016 to Tuesday October 11, 2016.

AbbVie’s Hep C Regimen Gets Breakthrough Therapy Designation
AbbVie has received breakthrough therapy designation from the US Food and Drug Administration for glecaprevir/pibrentasvir, an investigational, pan-genotypic regimen for treating chronic hepatitis C virus (HCV) in patients who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.

AbbVie’s HCV clinical development program is investigating a pan-genotypic (genotypes 1-6) regimen of glecaprevir/pibrentasvir (G/P). G/P is currently in Phase III development. AbbVie’s investigational regimen includes glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, dosed once daily as three oral tablets. Glecaprevir was discovered during an ongoing collaboration between AbbVie and Enanta Pharmaceuticals, a Watertown, Massachusetts-based biotechnology company developing small-molecule drugs for viral infections and liver diseases.

Source: AbbVie

FDA Accepts Allergan’s Application for Urinary Tract Infection Drug
The US Food and Drug Administration has accepted for filing a supplemental new drug application by Allergan for Avycaz (ceftazidime and avibactam), seeking the addition of new Phase III clinical trial data evaluating the drug in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. The FDA granted priority review status to this application and is expected to take action on the filing in the first quarter of 2017.

Avycaz was approved in the US in February 2015 for adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and cUTI, including pyelonephritis, caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas aeruginosa. In June 2016, the FDA approved the addition of data from a Phase III clinical trial to the label that evaluated the safety and efficacy of Avycaz, in combination with metronidazole, for the treatment of cIAI.

Source: Allergan

Roche Gets Breakthrough Therapy Designation for Anticancer Agent…
Roche has received a second breakthrough therapy designation from the US Food and Drug Administration (FDA) for Alecensa (alectinib), an anaplastic lymphoma kinase (ALK) inhibitor for advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor. Alecensa received its first FDA breakthrough therapy designation in June 2013 for ALK-positive NSCLC patients whose disease progressed on treatment with crizotinib.

Alecensa is currently available in the US and Israel to ALK-positive metastatic NSCLC patients who have progressed on or are intolerant to crizotinib, and in Japan to ALK-positive unresectable, recurrent or advanced NSCLC patients.

Source: Roche

…And for Autoimmune Drug Candidate
Roche has been granted breakthrough therapy designation by the US Food and Drug Administration (FDA) for Actemra/RoActemra (tocilizumab) for giant cell arteritis, a chronic autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.

Actemra/RoActemra is an anti-IL-6 receptor biologic, available in both intravenous and subcutaneous formulations, for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). Actemra/RoActemra can be used alone or with methotrexate (MTX) in adults who are intolerant to, or have failed to respond to, other anti-rheumatic medications.

The Actemra/RoActemra IV formulation is approved in most major countries for polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in children two years of age and older. In Europe, Actemra/RoActemra is also approved for use in patients with severe, active and progressive RA who previously have not been treated with MTX.

Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005.

Actemra/RoActemra is approved in 115 countries worldwide. Actemra/RoActemra is also being investigated in a global Phase III clinical study for patients with systemic sclerosis (SSc). Actemra/ RoActemra was granted breakthrough therapy designation for SSc by the FDA in June 2015. Actemra/RoActemra had 2015 sales of CHF 1.432 billion ($1.449 billion).

Source: Roche

CEL-SCI Reports Clinical Hold on Head and Neck Cancer Study
Cel-Sci Corporation, a Vienna, Virginia-based biotechnology company developing immunotherapies, has received verbal notice from the US Food and Drug Administration (FDA) that Multikine, its leukocyte interleukin injection in Phase III clinical trial in advanced primary head and neck cancer, has been placed on clinical hold. The company was also told to expect a formal letter from the FDA, and it said it will work with the agency to obtain the release of the clinical hold.

Source: Cel-Sci

Nicox Gets Complete Response Letter from the FDA
Nicox, a Sophia Antipolis, France-based ophthalmic research and development company, has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding a new drug application (NDA) for AC-170, its proprietary cetirizine eye drop formulation for ocular itching associated with allergic conjunctivitis. The FDA’s stated reason for the CRL pertains solely to a GMP inspection at a third-party facility producing the active pharmaceutical ingredient, cetirizine, and supplying it to the manufacturer of the finished product.

Nicox has been contacting its suppliers to assess the timeline for the API manufacturer to address the FDA’s concerns. Once these have been addressed, Nicox will then resubmit the AC-170 NDA. The safety and efficacy data submitted by Nicox have not resulted in the FDA requesting further clinical or non-clinical testing for the approval of AC-170. The CRL also did not include concerns related to the finished product manufacturing facility.

Cetirizine, the active ingredient in Johnson & Johnson’s allergy medication, Zyrtec, is a second generation antihistamine and mast-cell stabilizer that binds competitively to histamine receptor sites to reduce swelling, itching and vasodilation. Zyrtec was approved by the FDA in September 1996.

Source: Nicox