AstraZeneca, Novartis, and Shire 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, AstraZeneca, Janssen, Merck KGaA, Novartis, Shire, Teva, and Valeant.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday February 22, 2017 to Tuesday February 28, 2017.
EMA Positive on AbbVie’s Combo Hep C Regimen
AbbVie has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for a shorter, eight-week treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets) as an option for previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) and minimal to moderate fibrosis.
Viekirax + Exviera is currently approved in the European Union (EU) as a 12-week treatment for GT1b chronic HCV-infected patients without cirrhosis or with compensated cirrhosis. The combination regimen is also approved in the EU for treating GT1 HCV infection, including patients with compensated cirrhosis. Viekirax is individually approved in the EU for treating GT4 chronic HCV infection.
Viekirax tablets consist of the fixed-dose combination of paritaprevir 150mg and ritonavir 100mg with ombitasvir 25mg, dosed once daily. Exviera tablets consist of dasabuvir dosed twice daily. The combination regimen Viekirax + Exviera is taken with or without ribavirin, dosed twice daily based on patient type for 12 weeks except in GT1a patients with compensated cirrhosis who should take it for 24 weeks with ribavirin.
Paritaprevir, one of the active ingredients in Viekirax, was discovered during an ongoing collaboration between AbbVie and Enanta Pharmaceuticals, a research and development-focused biotechnology company headquartered in Watertown, Massachusetts, for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie’s other investigational medicines for the treatment of chronic hepatitis C.
EMA Positive on AstraZeneca’s Potassium Therapy
AstraZeneca has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of ZS-9 (sodium zirconium cyclosilicate), AstraZeneca’s drug for treating hyperkalemia, high potassium levels in the blood serum caused by cardiovascular, renal, and metabolic diseases.
In clinical trials, sodium zirconium cyclosilicate was shown to lower serum potassium levels in patients with acute and chronic hyperkalemia, according to AstraZeneca.
The CHMP’s opinion will be advanced to the European Commission (EC) for adoption of a decision on marketing authorization for the European Union (EU). EC’s final decision will be applicable to all 28 EU member countries plus Iceland, Norway, and Liechtenstein.
Sodium zirconium cyclosilicate is being developed by ZS Pharma, a subsidiary of AstraZeneca. It is currently also under regulatory review in Australia and by the US Food and Drug Administration in the US, with decisions expected in the first half of 2017.
EMA Positive on Expanding J&J’s Multiple Myeloma Drug Indication
Janssen-Cilag International, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which recommends broadening the existing marketing authorization for Darzalex (daratumumab) to include a combined-therapy indication for treating multiple myeloma.
If approved by the European Commission (EC), daratumumab, the active ingredient in Darzalex, can be used in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone, for treating adult patients with multiple myeloma who have received at least one prior therapy.
Daratumumab, CD38-directed monoclonal antibody, first received conditional approval from the EC in May 2016 as a monotherapy for treating adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.
The CHMP positive opinion follows a decision by the US Food and Drug Administration in November 2016 to approve the expanded use of daratumumab in combination with bortezomib/dexamethasone or lenalidomide/dexamethasone in patients with multiple myeloma who have received at least one prior therapy.
In August 2012, Janssen Biotech, also one of the Janssen Pharmaceutical Companies of J&J, and Genmab entered a worldwide agreement granting Janssen an exclusive license to develop, manufacture, and commercialize daratumumab.
Source: Johnson & Johnson
FDA Grants Priority Review to Merck KGaA’s Immuno-Oncology Drug
The US Food and Drug Administration (FDA) has granted priority review to Merck KGaA and Pfizer the biologics license application for avelumab for treating locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy.
This BLA, the second one for avelumab, was submitted by EMD Serono, the biopharmaceutical business of Merck KGaA. The FDA has set a Prescription Drug User Fee Act target action date of August 27, 2017 for this indication. A prior BLA was filed by the company that was accepted and granted priority review by the FDA in November 2016 for treating metastatic Merkel cell carcinoma. The FDA’s priority review status reduces the review time from 10 months to a goal of six months from the day of filing acceptance.
Avelumab is an investigational, fully human anti-programmed death (PD)-L1 antibody that is being jointly developed and will be jointly commercialized by Merck KGaA and Pfizer under a November 2014 agreement formed by the two companies [hyperlink https://connect.dcat.org/blogs/pharma-news/2014/11/17/pfizer-merck-kgaa-form-potential-2-billion-immuno-oncology-pact]. Under the agreement, Merck KGaA received an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments up to approximately $2 billion. Both companies will jointly fund all development and commercialization costs, and all revenues obtained from selling any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be shared equally.
In December 2015, Merck KGaA and Pfizer initiated a Phase III study of avelumab in the first-line setting as a maintenance treatment for locally advanced or metastatic urothelial carcinoma, which is currently enrolling patients.
Source: Merck KGaA
FDA Grants Novartis Priority Review for Lung Cancer Drug
The US Food and Drug Administration (FDA) has accepted for filing and has granted priority review to a supplemental new drug application submitted by Novartis for the expanded use of Zykadia (ceritinib) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC). Novartis is seeking a specific indication for treating patients whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The FDA also granted breakthrough therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.
Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal fusion protein that promotes the development and growth of certain tumors in cancers, including NSCLC, according to Novartis. Zykadia is currently approved in over 64 countries.
EMA Positive on Novartis’ Combo Lung Cancer Therapy
Novartis has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) to treat advanced or metastatic non-small cell lung cancer (NSCLC). Novartis is seeking a specific indication for treating patients whose tumors express the BRAF V600 mutation.
The European Commission (EC) is expected to deliver its final decision within two months. The decision will be applicable to all 28 European Union (EU) member states plus Iceland and Norway. In Europe, Tafinlar with Mekinist is approved as a combination therapy for treating patients with unresectable or metastatic melanoma who have a BRAF V600 mutation.
The regulatory status of the combination therapy in other countries includes a breakthrough therapy designation in the US granted by the US Food and Drug Administration (FDA) in 2015 for advanced or metastatic BRAF V600-positive NSCLC patients and priority review granted by the FDA in November 2016. Combined use of Tafinlar and Mekinist is also approved in the US, Australia, Canada, and additional countries for patients with unresectable or metastatic melanoma whose tumors tested positive for the BRAF V600 mutation.
Tafinlar and Mekinist target different kinases within the serine/threonine kinase family, BRAF and MEK1/2, respectively, which is implicated in NSCLC and melanoma, among other cancers, according to Novartis. When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more than either drug alone. The combination therapy is currently being investigated in an ongoing clinical trial program across a range of tumor types. The safety and efficacy profile of the Tafinlar and Mekinist combination has not yet been established outside of the approved indications.
Tafinlar and Mekinist are also indicated separately in more than 40 countries, including the US and EU, as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Novo Nordisk Files Diabetes Drug for Approval in Japan
Novo Nordisk has submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for, a glucagon-like peptide-1 (GLP-1) analogue for treating Type 2 diabetes.
The Japanese filing follows the recent regulatory submissions for the drug to the US Food and Drug Administration, the European Medicines Agency, Health Canada, and SwissMedic.
Source: Novo Nordisk
Shire Gains Positive EMA Opinion on Hypoparathyroid Drug
Shire has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending a conditional marketing authorization for Natpar (rhPTH[1-84]), a recombinant human parathyroid hormone (PTH) for treating chronic hypoparathyroidism. Shire is seeking a specific indication for the adjunctive treatment of adult patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone.
Hypoparathyroidism, a rare disease involving inadequate levels of PTH, is designated as an orphan disease by the European Commission (EC). The EC will now consider the CHMP positive opinion in its final decision, which is expected later in 2017.
If approved, Natpar will be made available in the European Union as a 25 mcg, 50 mcg, 75 mcg, and 100 mcg once-daily injection. Natpar is approved in the US under the trade name Natpara (parathyroid hormone).
FDA Grants Priority Review to Teva’s Neurological Drug
Teva Pharmaceutical Industries has been granted priority review by the US Food and Drug Administration (FDA) for deutetrabenazine, a drug for treating tardive dyskinesia, a movement disorder that is usually associated with treatment for psychiatric conditions like schizophrenia and bipolar disorder. The FDA has assigned a Prescription Drug User Fee Act goal date of August 30, 2017.
Tardive dyskinesia is a movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk, and extremities associated with treatment by medications of psychiatric conditions such as schizophrenia and bipolar disorder.
Source: Teva Pharmaceutical Industries
Valeant Resubmits Application for Glaucoma Drug
Valeant Pharmaceuticals International‘s wholly owned subsidiary, Bausch + Lomb, and Nicox, a Valbonne, France-headquartered pharmaceutical company, have resubmitted a new drug application (NDA) to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024% for treating glaucoma or ocular hypertension.
Latanoprostene bunod is an intraocular pressure-lowering single-agent eye drop dosed once daily for treating patients with open angle glaucoma or ocular hypertension. The data submitted in the NDA support latanoprostene bunod as a nitric-oxide donating prostaglandin F2α analog for ophthalmic use. Latanoprostene bunod was licensed by Nicox to Bausch + Lomb.