First, we go local, with two announcements from the European Medicines Agency (EMA). Then, an article about the micro level checks on which existing molecules can be repurposed to treat SARS-CoV-2. Lastly, a Science article reveals that excipients (drug vehicle/medium) may not be as inert as we thought.
We start with the withdrawal of the marketing authorisation application for Abilify MyCite. Otsuka Pharmaceutical Netherlands decided to pull back its marketing application for the drug-device combination of aripiprazole and an ingestible sensor for monitoring the medication ingestion because they couldn’t resolve the EMA’s concerns.
In theory, this was an interesting combination, because aripiprazole is used to treat manic episodes in schizophrenia and bipolar disorder, but it’s not always easy to ensure the patient takes his or her medication. By adding an ingestible sensor with the ability to transmit data on the date and time of ingestion to a wearable device, it was possible to help the patient, doctors and caregivers monitor if and when the medicine was ingested.
Unfortunately, there was not sufficient evidence that Abilify MyCite was able to reliably measure intake of the medicine in the target population, and its application was withdrawn.
Next, a news feature on the EMA website states that they are reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. If you’d like to read the newsletter issue in which I mentioned these results, just head to the blog post about it.
Repurposing old drugs for a new virus
All SARS-CoV-2-related papers are being accelerated in their publication, and this Nature article is no exception. So, while we must read it cautiously, there is interesting information in it.
The authors state that repurposing known drugs “could significantly accelerate the deployment of novel therapies for COVID-19”, and to find suitable candidates they searched a library of known drugs with approximately 12,000 clinical-stage or FDA-approved small molecules.
According to the authors, “Since most of the molecules identified in this study have already advanced into the clinic, the known pharmacological and human safety profiles of these compounds will enable accelerated preclinical and clinical evaluation of these drugs for the treatment of COVID-19”.
Excipients are inert…or are they?
The last highlight of the week goes to a (paywalled) article published in Science in which researchers systematically investigate the activity of approved inactive ingredients against biologically relevant molecular targets.
After performing computerised screening, in vitro testing, and investigating population exposure, they found that although most excipients deserve their status as inert, many approved excipients may directly modulate physiologically relevant targets.
I reckon we might hear more about the putative biological activity of excipients in the future.
Other posts you may like:
- November highlights from the Biopharma Newsletter
- New to medical devices? Here are 3 insights about Clinical Evaluation Reports
- Are you an aspiring medical writer? Apply for the Geoff Hall scholarship
- This week, less is more
- How AI and gaming can improve pharma and medtech
- Biopharma this week—(nearly) COVID-free edition