News 15/12/2544

News 15/12/2544

AVENTIS PASTEUR MSD RECALLS HEPATITIS VACCINE
Aventis Pasteur MSD, the European vaccines joint venture set up by Merck and Aventis, announced the recall of all stocks of its VAQTA hepatitis A vaccine because of concerns it might not be potent enough to protect people against the travel disease.

FDA APPROVES NOVEL AGENT TO PREVENT DEEP VEIN THROMBOSIS
French biopharmaceutical maker Sanofi-Synthelabo and Dutch chemical conglomerate Akzo Nobel said that they have received approval from the US Food and Drug Administration (FDA) to market their novel antithrombosis therapy, Arixtra (fondaparinux sodium).

Aventis Pasteur MSD Recalls Hepatitis Vaccine

LONDON (Reuters Health) Dec 07 - Aventis Pasteur MSD, the European vaccines joint venture set up by Merck and Aventis, announced the recall of all stocks of its VAQTA hepatitis A vaccine this week because of concerns it might not be potent enough to protect people against the travel disease.

The firm said the withdrawal involves pre-filled syringes of VAQTA vaccine for adults and VAQTA K for children. The vaccine is made by Merck and loaded into syringes in the UK by Evans Vaccines, part of PowderJect.

A spokesman for the joint venture said: "The problem is an apparent reduction in the potency of the vaccine, but only in a fraction of the syringes." However, because of the difficulty of identifying which syringes were affected, it had been decided to recall every batch.

A spokesman for PowderJect said the exact nature of the problem was not clear. "All of the processes that we use are all fully agreed by Merck before we use them," he said.

Ralf Ehret, commercial director of Aventis Pasteur-MSD's German unit, said 532,000 doses of the vaccine, worth 12 million euros, were sold in Europe in 2000.

FDA Approves Novel Agent to Prevent Deep Vein Thrombosis

WASHINGTON (Reuters Health) Dec 10 - French biopharmaceutical maker Sanofi-Synthelabo and Dutch chemical conglomerate Akzo Nobel said on Monday that they have received approval from the US Food and Drug Administration (FDA) to market their novel antithrombosis therapy, Arixtra (fondaparinux sodium).

The companies said that they received FDA approval to market the long-anticipated drug for the prophylaxis of deep vein thrombosis in patients undergoing hip fracture surgery, hip replacement surgery or knee replacement surgery. According to the FDA, Arixtra is the first synthetic anticoagulant to receive approval for these indications.

Arixtra is the first of a new class of agents designed to inhibit Factor X. The drug was discovered by Sanofi-Synthelabo in conjunction with Akzo Nobel subsidiary Organon Pharmaceuticals. It is now expected to compete with Aventis SA's anticoagulant drug Lovenox (enoxaparin), the present market leader.

The companies said that the US launch would occur in the first quarter of 2002. Arixtra is currently under regulatory review in the European Union.

Sanofi-Synthelabo said that clinical investigations are now being conducted to extend the presently approved indications.

Use of Arixtra is contraindicated in patients weighing less than 50 kg and those with severe renal impairment. In the clinical trials, the most common side effects were bleeding complications.

In addition, the FDA said that the product's label would have a "black box" warning stating that Arixtra should not be used in situations when spinal anesthesia or a spinal puncture is employed. The agency noted that such use could potentially result in a blood clot developing in the spine, which could cause long-term or permanent paralysis.