July 2007 PBAC Outcomes - Deferrals

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Drug and Form

Drug Use and Type

Listing Requested by Sponsor

PBAC Outcome and Comment

AMINO ACIDS – SYNTHETIC, FORMULA
and
AMINO ACID SYNTHETIC FORMULA supplemented with LONG CHAIN POLYUNSATURATED FATTY ACIDS
and 
PROTEIN HYDROLYSATE FORMULA with MEDIUM CHAIN TRIGYLCERIDES 

Wyeth Australia Pty Ltd
Minor submission
Treatment of cow’s milk protein allergy (CPMA) Review of the decision to recommend that soy protein no longer be used to treat cow’s milk protein allergy in infants. The PBAC was sympathetic to the submission’s claims that soy protein formula could represent appropriate first line treatment of infants with cow’s milk protein allergy based on its safety, efficacy and tolerability. 

The PBAC noted that the National Health and Medical Research Council, Food Standards Australia New Zealand and the American Academy of Paediatrics all recommended the use of soy protein based formula for the treatment of cow’s milk protein allergy. 

The PBAC considered the concern of the Nutritional Products Working Party, with respect to a high aluminium content in soy formulas, has been resolved.

The PBAC recognised that for less severe patients, the usual standard of care is to use soy protein before resorting to protein hydrolysate formulae.

The PBAC thus deferred the application to discuss the matter further with the Nutritional Products Working Party.
Sponsor’s comments No Comment