The European Medicines Agency has approved a new hybrid medicine for the treatment of chronic Pseudomonas aeruginosa infection in cystic fibrosis (CF).
At its latest meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Tobramycin PARI (tobramycin) for the management of chronic pulmonary Pseudomonas aeruginosa infection in CF patients aged six years and older.
Tobramycin PARI is a hybrid medicine (contains the same active substance) of TOBI Nebuliser solution which has been authorised in the EU since 10 December 1999. However, the new product contains a different strength of tobramycin and is administered using a different nebuliser device, allowing it to be inhaled over a shorter period. If the EMA recommendation is accepted by the European Commission, Tobramycin PARI will be available as a 170 mg nebuliser solution. The most common side effects that have been seen with the medication are cough and dysphonia.
Detailed recommendations for the use of Tobramycin PARI will be provided after the marketing authorisation has been granted by the European Commission.