In treatment news this November EMA reports on new COPD medicines and a UK body plans do discourage the use of a previously approved asthma drug.
EMA report on newly approved COPD medicines published
The European Medicines Agency (EMA) has released European public assessment reports (EPAR) on three COPD medicines for relief of symptoms in adult COPD patients. The medicines, for which approval was issued in September, are Enurev Breezhaler, Tovanor Breezhaler, and Seebri Breezhaler, and Novartis was the applicant for all three.
The EMA publishes an ‘EPAR’ for every medicine granted marketing authorisation by the European Commission. The newly published reports explain how the EMA Committee for Medicinal Products for Human Use (CHMP) assessed these medicines and set out recommendations on their conditions for use. The Committee agreed that they provide modest but relevant lung function improvement, and were seen to improve the symptoms of COPD. It also agreed that the requirement to use the medicines only once per day increases the likelihood of compliance with treatment. No major safety concerns were recorded, with the only side effects similar to other medicines in the ‘anticholinergic bronchodilator’ family.
NICE plans to recommend against use of Novartis asthma drug
NICE, the UK’s National Institute for Health and Clinical Excellence, has announced that it plans to discourage the use of the severe asthma drug Xolair – or Omalizumab – produced by Novartis. The Institute had previously recommended it for adult use only.
NICE is the body responsible for deciding whether or not medicines should be provided by the UK’s health service. It has said that it changed its opinion on the drug following the evolution of clinical evidence, and now plans to recommend it neither for children nor adults.
The process is still at review stage, and NICE has said the responsibility is now on the Novartis to respond to the evidence. More information