This week our industry insights look at news highlighting the importance of full disclosure in the promotion of medicines, EU recommendation for the approval of an antibody-drug for the treatment of NSCLC, and a popular oral decongestant that could be removed from the US market.
Novartis has been found to have seriously breached the ABPI Code of practice for the Pharmaceutical Industry. A(nother) cautionary tale from Novartis. The United Kingdom drug marketing body, the Prescription Medicines Code of Practice Authority, has found breaches relating to a Novartis website in the promotion of Mayzent (siponimod). This was raised by an anonymous healthcare professional noting that the website referred to Mayzent initiation in patients with a history of myocardial infarction and heart failure without making it clear that the drug was absolutely contraindicated in patients with a history of myocardial infarction or heart failure in the previous six months. This was found to be in breach of a number of clauses, including clause 2, which involves a company bringing “discredit upon, or reducing confidence in, the pharmaceutical industry”.
AstraZeneca and Daiichi Sankyo’s Enhertu are recommended for approval for use in the European Union for patients with HER2 non-small cell lung cancer (NSCLC).
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended that Enhertu – a HER-2 directed antibody conjugant – is approved for use as a monotherapy for treatment of advanced NSCLC with an activating HER2 mutation following platinum-based chemotherapy. This is based on the results of the DESTINY-Lung02 trial, which demonstrated Enhertu had a confirmed objective response rate of 49% and a median duration of response of 16.8 months.
Phenylephrine is a popular oral decongestant, particularly after sales of pseudoephedrine were limited due to its illicit use in the production of methamphetamine. However, an FDA advisory panel has overwhelmingly agreed (16-0 vote) that oral phenylephrine does not work in relieving congestion. This may lead to the FDA banning the over-counter use of oral phenylephrine in the United States. The advisory panel did note that nasal sprays containing phenylephrine are still an effective decongestant.
