International Approvals: Prexige, Elaprase, Micera

Yael Waknine

August 13, 2007

August 13, 2007 — Health Canada has approved an expanded indication for lumiracoxib tablets, allowing their use for the treatment of osteoarthritis in adults, and for idursulfase 2-mg/mL solution for the treatment of Hunter syndrome. The European Commission has approved methoxy polyethylene glycol-epoetin beta for the continuous treatment of anemia associated with chronic kidney disease.

Lumiracoxib ( Prexige) for Osteoarthritis in Canada

On July 23, Health Canada approved an expanded indication for lumiracoxib (Prexige, Novartis Pharmaceuticals Canada, Inc), allowing its use for the acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) in adults.

Although use of lumiracoxib previously was restricted to knee OA, the disease usually involves the hands and weight-bearing joints such as hips, knees, feet, and spine.

According to a company news release, lumiracoxib differs from other selective cyclooxygenase-2 (COX-2)-selective inhibitors in that it is rapidly cleared from the body, reaches a higher concentration in the joint synovial fluid, and is preferentially retained in inflamed tissue, allowing for once-daily dosing.

One-year data from the TARGET study (n = 18,325) showed that lumiracoxib was associated with a 79% decrease in the rate for upper gastrointestinal complications compared with the nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen in patients not receiving aspirin therapy. Data subanalyses further revealed that lumiracoxib decreased the risk for ulcer complications within the first month of use and offered significant benefit compared with naproxen in older patients at increased risk. Data presented at the 2007 Annual European Congress of Rheumatology also revealed that lumiracoxib had a significantly smaller effect on blood pressure than ibuprofen. "These new results are important because approximately 40 per cent of patients with osteoarthritis also have high blood pressure," the company says in a news release.

As with other NSAIDs, lumiracoxib should be used at the lowest possible dose for the smallest possible duration consistent with treatment goals. To ensure that lumiracoxib is appropriately prescribed, the company is launching health education programs for Canadian physicians and pharmacists.

In addition, a comprehensive, long-term study has been launched to monitor 20,000 Canadian patients receiving selected NSAIDs and COX-2 inhibitors (including lumiracoxib).

Lumiracoxib previously was approved by the European Commission for the symptomatic treatment of knee and hip OA. It has not been approved by the US Food and Drug Administration.

Idursulfase Solution (Elaprase) for Hunter Syndrome in Canada

On July 13, Health Canada approved idursulfase 2-mg/mL solution (Elaprase, Shire Human Genetic Therapies, Inc) for the treatment of Hunter syndrome (Mucopolysaccharidosis [MPS] 2).

The drug was granted a priority review, the company says in a news release. Previously, idursulfase had been made available to Canadian patients on a limited basis through Health Canada's Special Access program this year.

Hunter syndrome is a rare genetic condition caused by an absence or deficiency of iduronate-2-sulfatase, a lysosomal enzyme. It usually becomes apparent in children aged 18 to 36 months and is characterized by symptoms such as growth delay, joint stiffness, and coarsening of facial features. Severe cases can lead to respiratory and cardiac problems, liver and spleen enlargement, neurologic deficits, and death.

"It is estimated that approximately 40 people in Canada and 2,000 people worldwide are afflicted with MPS [2]," the company says. Although idursulfase therapy does not cure MPS 2, if started early, it can have a significant effect on the course of the progressive disease.

Idursulfase is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line. The recommended dose is 0.5 mg/kg of body weight administered every week as an intravenous infusion for a period of 1 to 3 hours.

The approval was based on data from a 53-week, randomized, double-blind, phase 2/3 trial showing that idursulfase therapy significantly increased mean 6-minute walk distance by 35 m relative to placebo. Treatment was generally well tolerated, with mild to moderate infusion reactions most commonly reported. Other adverse events observed in more than 30% of patients occurred with similar frequency in the active vs placebo group and included pyrexia (63% vs 59%), headache (19% vs 14%), and arthralgia (10% vs 9%).

Because of the risk for severe and potentially fatal anaphylactic reactions, medical support should be readily available during idursulfase infusions. If a severe reaction occurs, the infusion should be immediately suspended and appropriate treatment initiated. If symptoms resolve, the infusion may be resumed at a lower rate.

Patients who experience a severe infusion reaction can be treated by use of antihistamines and/or corticosteroids before or during subsequent infusions, a slower rate of idursulfase administration, and/or early discontinuation of the infusion.

A delay in therapy should be considered for patients with concomitant acute respiratory and/or febrile illness because of the increased risk for serious exacerbations resulting from infusion reactions.

Idursulfase solution was approved by the US Food and Drug Administration in July 2006.

Continuous ESA (Micera) for Anemia of Chronic Kidney Disease in EU

On August 13, the European Commission approved methoxy polyethylene glycol-epoetin beta (Micera, Roche) for the treatment of anemia associated with chronic kidney disease. The approval is valid in all 27 member states of the European Union.

The continuous erythropoietin receptor activator is indicated for use once every 2 weeks to increase hemoglobin (Hb) levels for the initial correction of anemia in patients not currently treated with an erythropoiesis-stimulating agent (ESA) such as epoetin alfa, epoetin beta, or darbepoetin alfa. It also may be used once monthly to maintain target Hb levels for patients converting from current ESA therapy.

The product has a different activity at the receptor level that more closely mimics the body's physiologic processes, the company says in a news release. It has not been approved by the US Food and Drug Administration.

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