FDA Drug and Device Approvals: May 6, 2004

May 06, 2004

Yael Waknine

May 6, 2004 — The U.S. Food and Drug Administration (FDA) has approved a new indication for etanercept, the Prodose system for accurate aerosol dosing, a bone graft product for tibia shaft fractures, a putty for making new posterolateral spinal fusions, and a pediatric indication for dorzolamide hydrochloride ophthalmic solution 2%.

Etanercept (Enbrel) for Moderate to Severe Plaque Psoriasis

On April 30, the FDA approved a new indication for etanercept (Enbrel, made by Immunex Corporation and marketed in North America by Wyeth), allowing its use in the treatment of patients aged 18 years and older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The approval was based on results of two phase III studies in which a total of 1,200 adults with plaque psoriasis were treated with etanercept for up to a year. Etanercept was administered at a dose of 50 mg twice a week for three months, followed by a "step-down" to a maintenance dose of 50 mg a week for the remainder of the study.

In one study, 46% of patients receiving twice-weekly doses of etanercept achieved a 75% or greater improvement in the Psoriasis Area Severity Index (PASI 75) at three months. At six months, the percentage of patients with a PASI 75 response was maintained after dose reduction.

The most common adverse events were injection site reactions.

Prodose Adaptive Aerosol Delivery System for Accurate Dosing

The Prodose Adaptive Aerosol Delivery (AAD, made by Profile Therapeutics) system was approved by the FDA on April 28. The Prodose inhaler has been used in Europe since March 2003 to deliver Promixin, an inhaled antibiotic for management of Pseudomonas aeruginosa lung infections, particularly in cystic fibrosis.

The AAD system is designed to deliver precise and reproducible doses of inhaled drug to any user regardless of age, size, or how they breathe. AAD technology analyzes users' breathing pattern to deliver a pulse of nebulized drug into the first half of inhalation, and is designed to deposit the drug in the required area of the lungs. The AAD feedback system alerts the user to treatment delivery and signals when the treatment is at an end. One Prodose AAD system can deliver various drugs at the required doses.

Bone Graft Product for Tibia Shaft Fractures

The genetically engineered bone graft product recombinant human Bone Morphogenetic Protein-2/Absorbable Collagen Sponge (rhBMP-2/ACS, made by Wyeth and marketed by Medtronic) was approved by the FDA on May 3. The device is indicated for the treatment of acute, open tibia shaft fractures in adults.

RhBMP-2, or dibotermin alpha, is a recombinant version of a naturally occurring protein that enhances bone healing while reducing the chances of infection. Placed on an absorbable collagen sponge, it is applied within 14 days of the initial fracture, after wound management and stabilization (with an intramedullary nail) by orthopaedic surgeons.

This product has been marketed in Europe since July 2003 under the name InductOs.

OP-1 Putty for Making a New Posterolateral Spinal Fusion

OP-1 Putty (made by Stryker Biotech) was approved by the FDA on April 7 under the Humanitarian Device Exemption Program. It is intended for use in making a new posterolateral spinal fusion in patients who have had a failed spinal fusion surgery and are not able to provide their own bone or bone marrow for grafting because of a condition such as osteoporosis, diabetes, or smoking.

OP-1 Putty is made from genetically engineered protein powder and bovine collagen that is mixed with saline solution and a thickening agent to form putty-like material. During surgery, the putty is placed on each side of thespinal levels that need to be fused.

The putty may help to form new bone by imitating the body's own method of bone healing and growth. It also gives a physical platform to support new bone growth.

Pediatric Indication for Dorzolamide Hydrochloride Ophthalmic Solution 2% (Trusopt)

Dorzolamide hydrochloride ophthalmic solution 2% (Trusopt, made by Merck) was approved by the FDA on April 15 for use in pediatric patients with elevated intraocular pressure (IOP).

The FDA based its approval on a three-month, multicenter, double-masked, active-treatment-controlled trial demonstrating the safety and IOP-lowering effects of the solution in pediatric patients.

Reviewed by Gary D. Vogin, MD

Yael Waknine is a freelance writer for Medscape.

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