AstraZeneca, Gilead, Novartis, and Sanofi Lead Pipeline News
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AstraZeneca, Gilead, Novartis, and Sanofi.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday December 7.2016 to Tuesday December 13,2016.
FDA OKs Review for AstraZeneca Bladder-Cancer Biologic
The US Food and Drug Administration has accepted for review a biologics license application from AstraZeneca and its global biologics research and development arm, MedImmune, for the anti-cancer biologic, durvalumab.
The FDA has also granted priority status review to durvalumab, which is a programmed death-ligand 1 human monoclonal antibody (mAb), with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. The FDA had also granted breakthrough therapy designation to darvalumab in February 2016.
The companies are seeking approval of the mAb for treating patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has progressed during or after one standard platinumâ€‘based regimen.
As part of a broad development program, durvalumab is being tested as monotherapy and in combination with tremelimumab in a Phase III trial as a first-line treatment for metastatic UC, regardless of eligibility for cisplatin-based chemotherapy.
The combination of durvalumab and tremelimumab is also being studied in Phase III trials in non-small cell lung cancer and head and neck squamous cell carcinoma and in Phase II and earlier trials in gastric cancer, pancreatic cancer, hepatocellular carcinoma, and blood cancers. AstraZeneca currently has more than 30 ongoing durvalumab clinical trials in combination with other imunno-oncology agents and targeted therapies.
Celgene Halts Trial for Combined Breast-Cancer Regimen
Celgene has decided not to move forward with a Phase III study of the anti-cancer drug Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension) in a combination regimen with chemotherapy drug carboplatin in favor of pursuing instead a combined Abraxane/immunotherapy regimen for treating breast cancer.
The company recently announced favorable results of a Phase II trial in which the combination regimen of Abraxane + carboplatin showed longer progression-free survival in the first-line treatment of metastic triple-negative breast cancer compared to weekly regimens of either Abraxane + gemcitabine or carboplatin + gemcitabine.
However, after taking into consideration the “rapidly changing breast cancer treatment landscape”, in which Celgene noted a “significant” focus on immuno-oncology treatments, Celgene has determined not to pursue Phase III development of the Abraxane + carboplatin regimen. The company will instead focus its breast cancer research support on combinations involving Abraxane and immunotherapies.
Abraxane is not indicated for the first-line treatment of metastatic breast cancer, or for the treatment regimens studied in the Phase II trial. Abraxane for injectable suspension is indicated for treating breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Gilead Files Hep C Drug Regimen for FDA Approval
Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen for treating hepatitis C.
The company is seeking approval for a regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for treating direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with Genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.
The SOF/VEL/VOX fixed-dose combination has been granted breakthrough therapy designation by the FDA for treating chronic genotype 1 HCV patients who have previously failed a nonstructural protein 5A inhibitor-containing regimen.
Source: Gilead Sciences
Novartis’ Eye Therapy Regimen Fails in Late-Stage Trial
Novartis has announced results of two Phase III clinical studies that show that pegpleranib in combination with Roche’s eye-drug, Lucentis (ranibizumab), failed to meet the primary endpoint of the studies for treating neovascular age-related macular degeneration.
Data from the two Phase III studies, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting.
Pegpleranib is a 32-mer pegylated DNA aptamer that selectively binds to platelet-derived growth factor (PDGF)-BB and PDGF-AB homo and hetero-dimers, respectively. In May 2014, Novartis signed a license and commercialization agreement with Ophthotech Corporation, a New York-headquartered biopharmaceutical company specializing in the development of therapeutics to treat diseases of the back of the eye, with a focus on age-related macular degeneration. Under the agreement, Novartis holds the exclusive rights to pegpleranib outside the US. Ophthotech holds the rights to pegpleranib in the US.
EMA Accepts Sanofi Application for Skin-Disease Biologic
The European Medicines Agency (EMA) has accepted for review a marketing authorization application from Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, for Dupixent (dupilumab), an investigational biologic for treating adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
A biologics license application for Dupixent was earlier accepted for priority review by the US Food and Drug Administration (FDA) in September 2016 with a Prescription Drug User Fee Act (PDUFA) date of March 29, 2017. The EMA and FDA have conditionally accepted Dupixent as the trade name for dupilumab.
Dupixent is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. In addition to AD in adults, Dupixent is being studied in pediatric AD, asthma, nasal polyposis, and eosinophilic esophagitis. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.