A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Samsung Bioepis, Tesaro, Johnson & Johnson, Teva Pharmaceutical Industries, GlaxoSmithKline, Astellas, and Bayer.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, September 13, 2017 to Tuesday, September 19, 2017.
EMA Advisory Committee Gives Positive Opinion on Samsung Bioepis’ Herceptin Biosimilar
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a biosimilar candidate referencing Roche’s cancer drug, Herceptin (trastuzumab), from Samsung Bioepis, an Incheon, South Korea-headquartered biopharmaceutical company. Herceptin, indicated for treating early breast cancer, metastatic breast cancer, and metastatic gastric cancer, is a top-selling drug for Roche with 2016 sales of CHF 6.78 billion ($7.04 billion).
The CHMP’s positive opinion will now be referred to the European Commission (EC), which will decide on the grant of a marketing authorization for the biosimilar candidate, Ontruzant. If a marketing authorization is granted by the EC, Ontruzant will be commercialized in the European Union by Merck & Co.
Samsung Bioepis is a joint venture between Samsung BioLogics, a contract biologics manufacturer based in Seoul, Korea, and Biogen. Samsung Bioepis is also advancing a pipeline of biosimilar candidates that includes six candidates that cover the therapeutic areas of immunology, oncology, and diabetes. Biogen and Merck & Co. are responsible for commercializing Samsung Bioepis’ products in designated territories worldwide following approval.
Source: Samsung Bioepis
Tesaro Receives Positive EMA Opinion for Cancer Drug
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on a marketing authorization application (MAA) for the cancer drug, Zejula (niraparib), from Tesaro, a Waltham, Massachusetts-headquartered, oncology-focused pharmaceutical company. The drug is slated by some analysts as a potential blockbuster drug.
The company's MAA is for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response or partial response to platinum-based chemotherapy.
This opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. Pending the decision by the EC, Zejula would be an oral, once-daily poly polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
Zejula was approved by the US Food and Drug Administration in March 2017 and is marketed by Tesaro in the US.
Zejula is estimated by some analysts for blockbuster drug with projected sales of nearly $1.1 billion by 2021, according to Clarivate Analytics.
Janssen Submits sNDA for Prostate Cancer Drug
Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking to expand the indication of Zytiga (abiraterone) in combination with prednisone and androgen deprivation therapy to include treating patients with high-risk metastatic hormone naïve prostate cancer (mHNPC) or newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer.
Zytiga is approved in combination with prednisone or prednisolone in 105 countries. In April 2017, Janssen submitted a Type II variation application to the European Medicines Agency, seeking to expand the existing marketing authorization for Zytiga in combination with prednisone or prednisolone to include treating men with mHNPC. Similar submissions have been made in Japan, Canada, Mexico, Brazil, Switzerland, Taiwan, Singapore, and the Philippines. If approved, these submissions will broaden the use of Zytiga in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.
Source: Janssen Biotech
FDA Gives Teva Priority Review for Leukemia Drug
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) of Teva Pharmaceutical Industries’ for the use of Trisenox (arsenic trioxide) injection in combination with all-trans retinoic acid for induction of remission and consolidation for certain types of acute promyelocytic leukemia (APL).
The new indication is for patients with newly diagnosed low or intermediate risk acute APL, whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Currently, Trisenox is indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
The FDA has accepted the sNDA for priority review with regulatory action expected in the first quarter of 2018.
Source: Teva Pharmaceutical Industries
FDA Advisory Committee Recommends GSK’s Shingles Vaccine
The Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) has voted to support the efficacy and safety of GlaxoSmithKline’s (GSK) Shingrix vaccine for preventing herpes zoster (shingles) in adults ages 50 and over.
The biologics license application was submitted to the FDA in October 2016.
GSK’s shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia, and Japan are underway.
FDA Advisory Committee Recommends GSK’s Self-Injectable Lupus Drug
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a new subcutaneous formulation of GlaxoSmithKline’s lupus drug, Benlysta (belimumab). The recommendation for usage is as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.
Benlysta is a human monoclonal antibody that has been licensed as an intravenous treatment for SLE in Europe since 2011. In this form, it is administered by healthcare professionals to patients as a weight-based dose of 10 mg/kg via a one-hour infusion in a hospital or clinical setting every four weeks.
The regulatory submission is seeking approval for Benlysta subcutaneous formulation in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. A final decision on approval will be made by the European Commission, which is anticipated in the next two to three months.
The Benlysta subcutaneous formulation is currently only approved for use in the US and was approved in July 2017. Further regulatory submissions are under review or planned in other countries during the course of 2017. The Benlysta intravenous formulation is licensed for use in over 70 countries worldwide, including the US and EU countries.
FDA Advisory Committee Recommends GSK’s Triple Therapy Inhaler for Pulmonary Disease
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease from GlaxoSmithKline (GSK) and Innoviva, a Brisbane, California-headquartered pharmaceutical company. Specifically, those who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The proposed brand name is Trelegy Ellipta.
Trelegy Ellipta is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in GSK’s Ellipta dry-powder inhaler. It is a once-daily single inhaler triple therapy. The proposed strength is FF/UMEC/VI 100/62.5/25 mcg.
A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission (EC). A final decision by the EC is anticipated by the end of 2017.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia, and Canada. FF/UMEC/VI is an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world.
FDA Accepts for Review Astellas' sNDA for Overactive Bladder Drug—put after the other Big Pharma companies
The US Food and Drug Administration (FDA) has accepted for review Astellas Pharma’s supplemental new drug application (sNDA) for the use of mirabegron in combination with solifenacin succinate 5 mg for treating overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The anticipated Prescription Drug User Fee Act goal date for a decision by the FDA is April 28, 2018. In the US, mirabegron and solifenacin succinate are marketed as Myrbetriq and Vesicare, respectively. Each is approved by the FDA as a monotherapy for treating OAB with symptoms of urge urinary continence, urgency and urinary frequency.
Source: Astellas Pharma
EMA Advisory Committee Recommends Bayer’s Thrombosis Drug
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has granted a positive opinion to update the label for Bayer’s oral Factor Xa inhibitor, Xarelto (rivaroxaban). The update would include a 10-mg once-daily dose for the extended prevention of recurrent venous thromboembolism (VTE).
This label update will apply to patients who have already received at least six months of standard anticoagulation therapy. Once approved, this will provide physicians with an additional treatment option alongside the 20-mg once daily dose already licensed in this indication. The final European Commission decision is expected by November 2017.
Rivaroxaban is a non-vitamin K antagonist oral anticoagulant and is marketed under the brand name Xarelto. Xarelto is approved for seven indications, including: preventing stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors; treating pulmonary embolism (PE); treating deep vein thrombosis (DVT); preventing recurrent PE and DVT in adults; preventing VTE in adult patients undergoing elective hip replacement surgery; preventing VTE in adult patients undergoing elective knee replacement surgery; preventing atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine.
Xarelto is approved for all indications in more than 130 countries.
Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Xarelto is marketed outside the US by Bayer and in the US by Janssen Pharmaceuticals.