Allergan, Janssen, Novo Nordisk, and Sanofi Lead Drug ApprovalsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Allergan, Janssen, Novo Nordisk, and Sanofi.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday November 16, 2016 to Tuesday November 29, 2016.
Allergan’s Eye Drug Therapy Gets FDA Nod
The US Food and Drug Administration has cleared Allergan’s XEN glaucoma treatment system (consisting of the XEN45 gel stent and the XEN injector) for use in the US. The XEN glaucoma treatment system reduces intraocular pressure in patients and is indicated for the management of refractory glaucomas where previous surgical treatment has failed, or in patients with primary open angle glaucoma, and pseudoexfoliative, or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
Allergan plans to launch the product in the US in early 2017. XEN is indicated in the European Union for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. It is also licensed for use in Canada, Switzerland, and Turkey.
EC OKs BMS’ Opdivo for New Cancer Indication
Bristol-Myers Squibb (BMS) has received approval from the European Commission (EC) for a new indication for Opdivo (nivolumab), BMS’ anti-cancer drug. The new indication for Opdivo is for treating adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin.
This approval allows for the expanded marketing of Opdivo in relapsed or refractory cHL in all 28 member states of the European Union (EU). Opdivo is currently approved in more than 57 countries, including the US, the EU, and Japan. In October 2015, the company’s Opdivo + Yervoy (ipilimumab) combination therapy received regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the US and the EU.
US indications for Opdivo include: as a single agent treating patients with BRAF V600 mutation-positive unresectable or metastatic melanoma; as a single agent for treating patients with BRAF V600 wild-type unresectable or metastatic melanoma; in combination with Yervoy for treating unresectable or metastatic melanoma; for treating patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy; for treating patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy; for treating patients with cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin; and for treating recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Source: Bristol-Myers Squibb
Janssen’s Cancer Drug Regimen OK’d by FDA
Janssen Biotech, a Johnson & Johnson company, has received approval from the US Food and Drug Administration (FDA) for its cancer therapy regimen consisting of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy.
The approval comes three months after a supplemental biologics license application was submitted to the FDA in August 2016. Darzalex received breakthrough therapy designation from the FDA for this indication in July 2016.
Darzalex is a CD38-directed cytolytic antibody injection that was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a primary immune deficiency (PI) and an immunomodulatory agent, or who are double refractory to a PI and immunomodulatory agent.
In August 2012, Janssen entered a worldwide agreement with Genmab, a Copenhagen, Denmark-headquartered biotechnology company, which granted Janssen an exclusive license to develop, manufacture, and commercialize Darzalex.
Source: Johnson & Johnson
EC OKs Janssen’s Psoriasis mAb for New Indication
Janssen-Cilag International, a Johnson & Johnson company, has received approval from the European Commission (EC) for a new indication for Stelara (ustekinumab), the company’s anti-inflammatory monoclonal antibody, in Chrohn’s disease. The EC approved the drug for treating adult patients with moderately to severely active Crohn’s disease.
This marketing authorization approval follows a positive opinion from the European Committee for Medicinal Products for Human Use of the European Medicines Agency issued in September 2016. This approval allows for the marketing of Stelara in all 28 member states of the European Union (EU) as well as the European Economic Area countries or Norway, Iceland, and Liechtenstein. Stelara also received approval from the US Food and Drug Administration in September 2016 for the additional Chrohn’s disease indication.
In addition to the new indication in Crohn’s diseae, Stelara is approved in the EU for treating moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, or psoralen plus ultraviolet A. It is also indicated in the EU for treating moderate to severe plaque psoriasis in adolescent patients 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, Stelara is approved alone or in combination with methotrexate for treating active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug therapy has been inadequate.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to Stelara, which is currently approved for the treatment of moderate to severe plaque psoriasis in 87 countries, psoriatic arthritis in 71 countries. and pediatric psoriasis in 34 countries.
Source: Johnson & Johnson
FDA OKs Novo Nordisk’s Diabetes Therapy
Novo Nordisk has received approval from the US Food and Drug Administration for Xultophy 100/3.6, its diabetes therapy. The product is now indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).
Xultophy 100/3.6 is a once-daily, single-injection fixed combination of long-acting insulin Tresiba (degludec) and the GLP-1 analogue Victoza (liraglutide). The company said it will launch the product in the first half of 2017.
Source: Novo Nordisk
FDA OKs Sanofi’s Combined Diabetes Therapy
The US Food and Drug Administration has approved Sanofi’s once-daily combined diabetes therapy, Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL. The product is indicated for adults with Type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.
Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection. Sanofi said the product will be available in US retail pharmacies in January 2017.
The combination was submitted for regulatory review in a total of 10 markets, including the European Union, where the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the marketing authorization of the product in November 2016.
Shire Launches Immune Globulin Therapy
Shire has launched Cuvitru [immune globulin subcutaneous (human), 20% solution], a subcutaneous 20% treatment option without proline available in the US to treat adult and pediatric patients 2 years old and up with primary immunodeficiency (PI).
The US Food and Drug Administration approved Cuvitru in September 2016 as a subcutaneous immune globulin (IG) replacement therapy for PI. Cuvitru offers a subcutaneous IG treatment option with the ability to infuse up to 60 mL (12 grams) per site and up to 60 mL per hour per site, as tolerated.
The availability of the drug expands Shire’s portfolio of intravenous and subcutaneous IG products available for PI patients. In June 2016, the company completed a decentralized procedure to support approval by 17 authorities in Europe for Cuvitru. The company expects to initiate additional global regulatory submissions for the drug in late 2016 and 2017.
Takeda Gets Conditional Nod from EC for Cancer Drug
Takeda Pharmaceutical Company has received a conditional marketing authorization from the European Commission for its anti-cancer drug, Ninlaro (ixazomib)capsules. Ninlaro is indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.
The decision to approve Ninlaro follows a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2016. The drug is now approved for use across the European Economic Area, which includes the European Union’s 28 member states as well as Norway, Liechtenstein, and Iceland. In addition, Ninlaro is licensed for use in the US, Canada, Israel, Australia, and Venezuela. Takeda has submitted marketing authorization applications for Ninlaro to a number of additional regulatory authorities around the world.
Ninlaro is an oral proteasome inhibitor that is also being studied across the continuum of multiple myeloma treatment settings as well as systemic light-chain amyloidosis. It was approved by the US Food and Drug Administration (FDA) in November 2015 following a priority review. In the US, Ninlaro is indicated in combination with lenalidomide and dexamethasone for treating patients with multiple myeloma who have received at least one prior therapy.
Ixazomib was granted orphan drug designation in multiple myeloma in both the US and Europe in 2011 and for systemic light-chain amyloidosis in both the US and Europe in 2012. Ixazomib received breakthrough therapy status by the FDA for relapsed or refractory systemic light-chain amyloidosis in 2014.
Source: Takeda Pharmaceutical Company
EC Extends Indication for Teva’s Cancer Drug
The European Commission (EC) has approved an indication extension to Teva Pharmaceutical Industries for Trisenox (arsenic trioxide) for use as a chemotherapy-free agent in treating acute promyelocytic leukemia (APL) in patients in Europe.
The EC’s decision, which follows a positive recommendation from the Committee for Medicinal Products for Human Use of the European Medicines Agency in October 2016, grants marketing authorization for first-line use of Trisenox in the 28 countries of the European Union. The indication extension is for newly diagnosed low- to intermediate-risk APL in combination with retinoic acid.
Trisenox was approved by the EC in March 2002 and by the US Food and Drug Administration in September 2000 for treating patients with relapsed or refractory APL.
Source: Teva Pharmaceutical Industries