Keeping Up to Date Easily: Senvelgo Oral Solution Case Study
Keeping Up to Date Easily: Senvelgo Oral Solution Case Study
Senvelgo oral solution is a new treatment option for cats with diabetes mellitus. Its arrival on the market in Great Britain is being met with great interest because it is a completely new type of treatment for diabetes in cats.
How does a new medicine like Senvelgo oral solution get to market?
Senvelgo oral solution is veterinary medicine that contains the active ingredient velagliflozin. This is a new type of diabetes treatment in veterinary medicine, although similar drugs have been in use in the treatment of type 2 diabetes in humans for several years.
In order to be able to market a veterinary medicine, such as Senvelgo for cats, the marketing company must obtain a marketing authorisation from the veterinary medicines regulator. In Great Britain, this is the Veterinary Medicines Directorate.
The process of awarding a marketing authorisation is a highly technical process involving the assessment of data that the company presents to the regulator. The data concerns the following aspects of the medicine:
Quality
Efficacy
Safety
The quality of a veterinary medicine
When treating an animal with a medicine, it is crucial to be able to depend on the quality of the product. This is why the regulatory process includes scrutiny of the quality and source of the ingredients, the manufacturing methods, and the quality control and stability of the finished product.
The efficacy of the veterinary medicine
The company must prove to the regulator that the medicine does what it is claimed to do. This usually involves conducting clinical trials in animals of the particular species with the relevant disease.
Safety of the veterinary medicine
The regulator assesses the product in terms of safety:
to the animal being treated with the medicine
humans who handle the medicine
the environment (although as medicines for the treatment of individual animals, as opposed to herds, are considered to have a negligible impact on the environment, there is limited assessment of this aspect).honey flavour.
Where to find out about a new medicine like Senvelgo oral solution
When a new veterinary medicine is authorised by the Veterinary Medicines Directorate, it is listed in the regulator’s Product Information Database along with every other veterinary medicine authorised for marketing in Great Britain. If you search for Senvelgo in the database you will reach a page that includes the Summary of Product Characteristics. This is the official regulatory information on the product. Essentially it is a summary of the marketing authorisation.
For instance, it specifies the use for which the product has been authorised, which in the case of Senvelgo oral solution is “For the treatment of diabetes mellitus in cats”. The Summary of Product Characteristics for Senvelgo oral solution contains a great deal of essential information for the prescriber on how to use the product for its treatment benefits. It also contains important advice on avoiding adverse effects by specifying when the product should not be used (the contraindications) and detailed advice on monitoring the therapy.
The information in the Summary of Product Characteristics for Senvelgo oral solution is also reproduced in the NOAH Datasheet Compendium.
Keeping up to date on medicines is necessary
It’s a professional necessity for a vet to keep up to date on veterinary medicines. The Summary of Product Characteristics is not a static document. It evolves as more knowledge about a medicine comes to light. When any new medicine is first authorised for marketing, it’s a fact that knowledge about its effects and adverse effects is limited. Pre-marketing clinical trials for new veterinary medicines usually include a few hundred animals treated for up to 6 months, at most. This means that only the most common adverse effects that can usually be detected by the time a medicine is marketed. This is the reason why marketed medicines (human and veterinary) are continuously monitored by regulators.
The Summary of Product Characteristics of a new medicine is updated as and when significant new knowledge comes to light. This might be new adverse effects, or more detail about the likelihood of an already recognised adverse effect, or new advice about how to use the product to prevent an adverse effect (such as avoiding prescribing the treatment for particular types of patient).
How can a vet keep up to date easily?
Don’t worry, there is no need to keep checking the Product Information Database or NOAH Compendium to see what has changed. By subscribing to Veterinary Prescriber, you will get a monthly update on changes to the Summaries of Products Characteristics, so you can easily see changes to the products that you usually use. As well as these changes, Veterinary Prescriber’s Monthly Medicines News also alerts you to changes to veterinary medicines regulations in general (there will be some major ones in 2024 when the revised Veterinary Medicines Regulations are expected to come into force).
Click here to find out how you can be sure of keeping up to date on medicines like Senvelgo oral solution as well as all the other benefits of subscribing to Veterinary Prescriber, such as access to independent reviews of new medicines, including Senvelgo oral solution.