FDA wants more data on Symbicort for kids

AstraZeneca Plc faces a delay in marketing its asthma drug Symbicort to young children in the United States after regulators asked for more information, dealing a blow to an important growth driver.

The medicine is already approved for patients aged 12 and over and the company is now seeking to sell it for the long-term maintenance treatment of asthma in 6-11 year-olds.

But the Food and Drug Administration (FDA) said AstraZeneca had not provided adequate data to establish the appropriate dose or doses of the drug’s two components—budesonide and formoterol—in this younger age group.

“We had expected Symbicort to increase market share after approval in children (currently 10 percent of U.S. prescriptions) and thus the delay could impact growth of the product going forward,” WestLB analyst Simon Mather said in a research note.

Due to its concerns, the FDA issued AstraZeneca with a Complete Response Letter (CRL), indicating it is not yet ready to approve the product.

“AstraZeneca is evaluating the CRL and will provide a response to the agency in due course,” the Anglo-Swedish company said in a statement on Monday.

Symbicort is a rival to GlaxoSmithKline Plc’s top-selling medicine Advair, which is already cleared for use in children as young as four. Symbicort’s approval for use by children is important to put it on a level footing.

Both Symbicort, which sold $2.0 billion worldwide last year, and Advair, which sold 4.1 billion pounds ($6.0 billion), are inhaled drugs combining a corticosteroid and a long-acting beta-agonist.

In addition to asthma, they are also both approved for treating for chronic obstructive pulmonary disease, or COPD, in adults.

AstraZeneca also said on Monday that the Swedish competition authorities had approved its sale of a portfolio of over-the-counter (OTC) products to Glaxo.

Under the deal, first announced last November, AstraZeneca will receive some $220 million, which the company will record as a gain in its second quarter accounts.

By Ben Hirschler
LONDON (Reuters)