Novartis Says FDA Approves Menveo Vaccination in Children, Not Infants

U.S. regulators approved Novartis AG’s Menveo meningococcal vaccine for use in children from 2 years of age, though they requested more information on use of the shot in infants.

The company will resubmit the application to the Food and Drug Administration in the coming months for use of the vaccine in babies aged 2 months to 12 months, Basel, Switzerland-based Novartis said today in a statement.

Novartis is counting on the inoculation to drive growth in its vaccine unit, where revenue dropped 74 percent to $361 million in the fourth quarter. The shot could generate as much as $500 million in annual revenue, according to Karl-Heinz Koch, an analyst at Helvea SA in Zurich. Menveo may compete with Sanofi-Aventis SA’s Menactra, a shot that is being reviewed by U.S. regulators.

“The U.S. approval in children from 2 years of age onwards is positive news,” Koch, who recommends buying the stock, said in a note to clients today. “However an approval in infants below the age of 2 years would give Menveo a competitive advantage over Menactra as most of the infections occur in this age group and Menactra shows only limited efficacy.”

The shares were unchanged at 52.80 Swiss francs as of 11:48 a.m. in Zurich trading.

The vaccine mimics technology used in Pfizer Inc.’s best- selling Prevnar shot and Novartis’s Menjugate, which protects against meningitis C. Pfizer’s pneumonia vaccines Prevnar and Prevnar13 had combined sales of $735 million in the third quarter of last year.

‘Procedural’

The FDA’s rejection of the application in infants is believed to be “procedural in nature,” and gives the company the chance to add clinical data to the file, Novartis said. Novartis will not need to run additional trials, Eric Althoff, a spokesman at Novartis, said in a phone call today.

Novartis will monitor the vaccine in three studies in the older age group after it reaches the market, the company said.

Meningococcal disease is a leading cause of meningitis, an infection of the membrane surrounding the brain and spine, as well as blood infection, which can lead to brain damage, learning disabilities, hearing loss and loss of limbs.

There are several types of the disease. The shot shields against the A, C, W-135 and Y strains of Neisseria meningitides at the same time, and, if approved, would be the first that can be given as early as 2 months of age, the company had said. The vaccine was approved in the U.S. for the 11 to 55 age group last year, and is registered in more than 40 countries for use in people older than 11.

About 2,600 people contract the disease every year in the U.S., of which about 10 to 15 percent die and roughly the same number suffer brain damage and other serious side effects, according to the National Institute of Neurological Disorders and Stroke.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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