AstraZeneca Experiences Approval Delays

AstraZeneca Experiences Approval Delays. The release of asthma drug, Symbicort, is being delayed for approval to young children.  Reuters said that regulators have asked Symbicort maker, AstraZeneca Plc, for additional information before it can consider allowing expansion of the drug’s use.

Symbicort is an inhaled combination medication that contains a corticosteroid and a long-acting beta-agonist and is used to treat asthma as well as chronic obstructive pulmonary disease (COPD) in adults.

Symbicort is approved for patients aged 12 and over, but AstraZeneca is hoping for approval for “long-term maintenance treatment of asthma in” children ages six to 11 said Reuters.

The Food and Drug Administration (FDA) said the drug maker has not yet given sufficient information to determine an appropriate dose or doses of the drug’s two medications—budesonide and formoterol—in the younger pediatric group, reported Reuters.  Because of this, the FDA is seeking additional information before issuing approval.

We had expected Symbicort to increase market share after approval in children

“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, quoted Reuters.

The FDA issued a Complete Response Letter (CRL), which stated that the agency is not ready to approve the medication, said Reuters.  The drug maker, in a statement today, said it “is evaluating the CRL and will provide a response to the agency in due course,” quoted Reuters.

Symbicort was approved in 2006 and its primary competitor is GlaxoSmithKline’s Advair, said the Wall Street Journal (WSJ), which has already been approved for pediatric patients as young as young as age four, said Reuters.  The delay is seen as a big setback to AstraZeneca.

The Journal pointed out that, according to Navid Malik, a Matrix Corporate Capital analyst, the delay “won’t help” AstraZeneca’s public image following concern expressed by the FDA over broadening its use of Seroquel, its antipsychotic medication.

We recently reported that Advair, Symbicort, and other inhaled corticosteroids might increase

We recently reported that Advair, Symbicort, and other inhaled corticosteroids might increase the risk of pneumonia in patients with COPD by as much as 70 percent, according to a news study.  The study, conducted by researchers at Wake Forest University Baptist Medical Center, was published in the Archives of Internal Medicine.

Advair and Symbicort are both known as long-acting beta-agonists (LABAs), a class of drugs used to treat asthma; both medications use a LABA with an inhaled steroid.  Other LABAs, such as Serevent and Foradil, do not contain a steroid.

Those taking a corticosteroid, either alone or with a LABA, increased their risk of developing pneumonia by 60 to 70 percent, which means that about one in every 47 people with COPD who uses a corticosteroid inhaler for a year is likely to develop pneumonia.

In December, we reported that one expert estimated that LABAs such as Symbicort, Severent, Foradil, and Advair might be responsible for about 14,000 deaths, according to an earlier Reuters report.  The comments were part of a confrontational meeting between the FDA and an advisory panel discussing how to handle increased risks experienced with the inhaled asthma medications, said Reuters.

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