Amgen and Celgene Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, Amgen, and Celgene.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday February 22, 2017 to Tuesday February 28, 2017.

FDA OKs AstraZeneca’s Combo Diabetes Drug
AstraZeneca has received approval from the US Food and Drug Administration for Qtern (10mg dapagliflozin and 5mg saxagliptin), a once-daily combination drug for treating Type-2 diabetes.

Qtern is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes who have inadequate control with dapagliflozin, 10mg, or who are already treated with dapagliflozin and saxagliptin.

Qtern combines two anti-hyperglycemic agents with complementary mechanisms of action in a once-daily tablet: dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.

SGLT-2 inhibitors reduce the reabsorption of glucose from the blood and enable its removal via the urine. These inhibitors have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c.

Source: Astrazeneca

Amgen Gains EC Approval for New Cholesterol-Drug Dosage
Amgen has received approval from the European Commission (EC) to change the marketing authorization for Repatha (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for treating high cholesterol, to include a new single-dose delivery option. The single-dose delivery option comprises an automated mini-doser (AMD) with a prefilled cartridge that provides a hands-free 420-mg dose of Repatha in a single injection per administration.

Approval from the EC grants a change to the centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union (EU). Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC. The Repatha AMD will be available in Europe this year depending on reimbursement requirements.

In 2015, Repatha gained marketing authorization in Europe as an every-two-week or monthly dosing regimen. In Europe, Repatha is approved as an adjunct to diet for treating high cholesterol in combination with statins or other lipid-lowering therapies in patients unable to control their low-density lipoprotein cholesterol with maximally tolerated statin doses, or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. Repatha is also approved in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolemia (age 12 and over).

In the US, the US Food and Drug Administration approved the single 420-mg monthly injection option in July 2016, which comprises a proprietary on-body infuser with prefilled cartridge known as the Pushtronex system for use with Repatha.

Repatha is approved in more than 40 countries, including the US, Japan, Canada, and in all 28 countries that are members of the EU. Applications in other countries are pending.

Source: Amgen

EC OKs Celgene’s Multiple Myeloma Drug as Monotherapy
The European Commission (EC) has granted approval to Celgene International Sàrl, a wholly-owned subsidiary of Celgene, a Summit, New Jersey-based biopharmaceutical company, for Revlimid (lenalidomide) as monotherapy for the maintenance treatment of multiple myeloma. The indication granted is specifically for adult patients with multiply myeloma who have undergone autologous stem cell transplantation.

The EC’s Revlimid marketing authorization has been updated to include this new indication, which expands on the existing multiple myeloma indications as combination therapy for treating patients not eligible for transplant who are newly diagnosed, or have received at least one prior therapy. The EC decision for the new indication approval follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in January 2017.

In February 2017, the US Food and Drug Administration expanded the existing indication for Revlimid in the US to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant.

Revlimid as combination therapy is approved in Europe, the US, Japan, and around 25 other countries for treating adults with previously untreated multiple myeloma who are not eligible for transplant. Revlimid is also approved in combination with dexamethasone in nearly 70 countries, including in Europe, the Americas, the Middle-East, and Asia, for treating patients with multiple myeloma. It is also approved in combination with dexamethasone in Australia and New Zealand for treating patients whose disease has progressed after one therapy.

In addition, Revlimid is approved in the US, Canada, Switzerland, Australia, New Zealand, several Latin American countries, Malaysia, and Israel for transfusion-dependent anemia. Other indications Revlimid is approved for include the treatment of patients with mantle cell lymphoma (MCL), in Europe and the US, and the treatment of patients with relapsed or refractory MCL after prior therapy, in Switzerland.

Source: Celgene 

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