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
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.