Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 03 November 2016 | By Michael Mezher
The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma.
Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma.
In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially lifesaving medicines for patients with severe or life-threatening conditions.
For a product to qualify for EAMS, it must be granted a promising innovative medicine (PIM) designation based on early (Phase I and/or II) clinical data and satisfy additional criteria including the severity of the condition the product is intended to treat and the level of improvement over previously authorized treatments.
Since EAMS approval is based on early clinical data, companies are required to provide MHRA with regular reports documenting adverse effects, and should notify the agency of changes to treatment protocols based on data gathered through the product's use.
Because these products are not yet licensed in the UK, MHRA says a positive EAMS assessment is intended to "inform doctors who may wish to prescribe the unlicensed medicine under their own responsibility," such as in cases where other options have been exhausted. Additionally, MHRA says that a positive EAMS assessment should not be considered to be an indication of future authorization of a product.
According to MHRA, the drug was accepted to EAMS for its potential to reduce tumor size after multiple attempts with other therapies.
Alongside the scientific opinion, MHRA has also issued treatment protocols for patients and healthcare professionals, as well as instructions for pharmacovigilance reporting for patients treated with the drug under EAMS.
Tags: EAMS, Early Access to Medicines Scheme, Opdivo, Nivolumab, Hodgkin's Lymphoma