AstraZeneca PLC (NYSE:AZN) reported that the U.S. FDA has permitted updates to the SYMBICORT® Inhalation Aerosol labeling, counting removal of the Boxed CAVEAT for serious asthma-linked outcomes. SYMBICORT marks as a combination formulation having budesonide, an ICS, and formoterol, a LABA bronchodilator in an inhaler.
In 2011, to further assess the LABAs safety when used together with ICS for the cure of asthma, the FDA needed the manufacturers of LABAs to perform similar double-blind, randomized, controlled clinical studies evaluating the inclusion of LABAs to ICS compared to ICS alone. The needed SYMBICORT trial started in late 2011.
AstraZeneca reported that the FDA assessed a total of four clinical studies involving 41,297 subjects. Three of the four studies included adolescents 12 years and older. One of the studies compared salmeterol/fluticasone to fluticasone, one assessed formoterol/mometasone to mometasone, and one compared SYMBICORT to budesonide. The fourth study included pediatric subjects 4-11 years and assessed fluticasone/salmeterol to fluticasone.
The data did not demonstrate a considerable jump in risk of a grave asthma-related event with ICS/LABA fixed-dose arrangement versus ICS alone. The studies did demonstrate that ICS/LABA combination drugs were more effective in lowering asthma attacks versus ICS alone. This supplementary information has been shown on the ICS/LABA labels.
The four trials were in favor of the decision to eradicate the Boxed CAVEAT for the ICS/LABA class. The medicines labels that contain both a LABA and ICS retain a Precaution and Warning associated to the increased risk of asthma-linked death when LABAs are utilized without an ICS to cure asthma.
The most common harmful reactions ≥3% seen in asthma pivotal studies of SYMBICORT comprised nasopharyngitis, upper respiratory tract infection, headache, sinusitis, pharyngolaryngeal pain, rhinitis, pharyngitis, back pain, influenza, stomach discomfort, vomiting, oral candidiasis and nasal congestion.
In the last trading session, the stock price of AstraZeneca gained more than 1% to close the day at $34.70.