Pfizer, Merck & Co., Teva, and Roche Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer, Merck & Co, Teva, and Roche.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, August 30, 2017 to Tuesday, September 5, 2017.

FDA OKs Pfizer’s ADC Mylotarg
The US Food and Drug Administration (FDA) has approved Pfizer’s Mylotarg (gemtuzumab ozogamicin), an antibody drug conjugate (ADC) for treating leukemia. The approval is for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children two years and older with relapsed or refractory CD33-positive AML.

Mylotarg is an ADC comprised of the cytotoxic agent, calicheamicin, attached to a monoclonal antibody targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90% of AML patients, according to Pfizer. When Mylotarg binds to the CD33 antigen on the cell surface, it is absorbed into the cell, and calicheamicin is released causing cell death, according to Pfizer.

Mylotarg was originally approved by the FDA in 2000 under an accelerated approval program for use as a single agent in first-relapse patients with CD33-positive AML who were 60 years or older. In 2010, Pfizer voluntarily withdrew Mylotarg after a confirmatory Phase III trial at that time did not show a clinical benefit, and the fatal induction toxicity rate was significantly higher in the Mylotarg arm of the clinical trial.

This is the second recent ADC approval from the FDA for Pfizer. In August 2017, the FDA approved Pfizer’s Besponsa (inotuzumab ozogamicin), another ADC, for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Source: Pfizer


EC OKs New Use for Merck & Co.’s Cancer Drug
The European Commission (EC) has approved Merck & Co.’s Keytruda (pembrolizumab), an anti-PD-1 therapy, for treating patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, Keytruda is approved for use as monotherapy for treating locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy as well as adults who are not eligible for cisplatin-containing chemotherapy.

The approval allows for the marketing of Keytruda in these two new indications in all 28 European Union member states plus Iceland, Lichtenstein, and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity.

Keytruda is indicated for treating various other cancers: advanced melanoma, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, and microsatellite instability-high cancer.

Source: Merck & Co.


Teva Gets FDA OK for Tardive Dyskinesia Drug
The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical Industries’ Austedo (deutetrabenazine) tablets as a new molecular entity for treating tardive dyskinesia, a condition affecting the nervous system, in adults.

Austedo was previously approved for treating chorea associated with Huntington’s disease in April 2017. Austedo is indicated for treating tardive dyskinesia in adults. Austedo is also indicated for treating chorea associated with Huntington’s disease.

Source: Teva Pharmaceutical Industries


Roche Gets New Indication for Arthritis Drug
The US Food and Drug Administration (FDA) has approved Roche’s rheumatoid arthritis (RA) drug, Actemra/RoActemra (tocilizumab), for a new indication. The drug was approved as an intravenous injection for treating chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older.

CRS has been identified as a potentially severe side effect of CAR-T cell therapy for certain cancers, according to Roche.

Actemra/RoActemra is an anti-IL-6 receptor biologic available in both intravenous and subcutaneous formulations for treating adult patients with moderate-to-severe active RA.

Source: Roche


EC OKs Expanded Use for Amgen’s Renal Disease Drug
The European Commission (EC) has granted Amgen marketing authorization of a pediatric formulation (granules in capsule for opening) for its renal disease drug, Mimpara (cinacalcet).

The approval indicates Mimpara for treating secondary hyperparathyroidism (HPT) in children aged three years and older with end‑stage renal disease on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy.

Approval from the EC grants a 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.

Mimpara was originally approved in the EU in 2004 and is an oral calcimimetic agent. The therapy is also approved in the EU for the reduction of hypercalcemia in adult patients with parathyroid carcinoma and with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated. Mimpara binds to the calcium-sensing receptor, resulting in a drop in PTH levels by inhibiting PTH synthesis and secretion, according to Amgen. In addition, the reductions in PTH lower serum calcium and phosphorus levels.

Source: Amgen

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