Hansa Biopharma, a leader in enzyme technology for rare immunological conditions, has just been granted access and reimbursement by the Spanish Minister of Health for its revolutionary Idefirix® treatment, allowing for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor.
This ground-breaking achievement follows the conditional approval granted by the European Medicines Agency in August 2020, providing hope and a potential new lease of life to patients in need.
At Hansa Biopharma, our mission is to make a difference in the lives of patients with rare immunological conditions. We are proud to be able to provide equitable access to care with our innovative treatment, Idefirix®.
We are delighted to announce that our treatment has been approved for reimbursement in Spain, allowing highly sensitized patients to be desensitized and potentially receive a lifesaving kidney transplant.
At the end of 2021, Spain’s kidney transplant waiting list had an alarming 4,000 registered patients – with up to one in five being highly sensitized. Despite this, the country managed to perform more than 3,000 kidney transplants annually, 90 percent of which came from deceased donors.
Idefirix® is now available in five of the most populous countries in Western Europe: Germany, France, UK, Italy, and Spain, following the reimbursement decision in Spain. These countries account for around two-thirds of the total kidney transplants from deceased donors performed in the continent. Additionally, this availability is especially important for highly sensitized patients, which comprise around 10-15% of all those on the transplant waiting list in Europe.
The news of Idefirix®’s approval in Spain is a major breakthrough for highly sensitized patients who often struggle to find a compatible organ. As the treating physician of the first patient who received Idefirix® as part of Hansa’s post-authorization efficacy study (PAES) in Europe7, Dr. Oriol Bestard, Chair of Nephrology and Kidney Transplantation at Vall d’Hebron University Hospital in Barcelona, expresses his enthusiasm for this innovative treatment.
He believes that it has the power to significantly improve the lives of those with the highest medical need. By providing more personalized and innovative desensitization options, Idefirix® has the potential to make incompatible kidney transplantation a reality for many.
As mandated by the EU Market Abuse Regulation, Hansa Biopharma AB is pleased to make a public announcement at 3:00pm CET on March 29, 2023. The information provided is of utmost importance and has been submitted for publication through the relevant contact persons.
About highly sensitized patients
Highly sensitized patients are faced with a multitude of challenges when it comes to finding a suitable donor, as their pre-formed antibodies, called donor specific antibodies (DSAs), can cause tissue damage and potentially transplant rejection.
As a result, highly sensitized patients comprise 10-15% of the total of patients on transplant waiting lists in the U.S. and Europe, and often spend longer time than average on the waitlist, which is associated with an increased mortality risk. Despite the complexity of their immunological profile, highly sensitized patients can still be candidates for successful transplants with the right donor.
About Idefirix® (imlifidase)
Immlifidase, derived from the Streptococcus pyogenes bacterium, is an enzyme with a remarkable ability to target and cleave all classes of IgG antibodies. This unique enzyme has the potential to revolutionize the way immunological treatments are administered, offering a targeted and efficient approach to combating immune disorders.
Imlifidase represents a promising new avenue for desensitizing transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of pre-existing antibodies that can wreak havoc on a donor organ during a transplant.
However, by using imlifidase to inactivate these antibodies, a window of opportunity is opened for a successful transplant. Once the antibodies are deactivated, the patient can begin receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection. In this way, imlifidase is proving to be an invaluable tool in the fight against transplant rejection.
Four phase 2 open-label, single-arm, six-month clinical trials were conducted to evaluate the efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG. The trials provided insight into the potential of this novel therapy to improve transplant outcomes and ultimately, the quality of life of transplant recipients.
Hansa is furthering the clinical evidence for Idefirix® with the collection of additional efficacy and safety data from an observational follow-up study and a post-approval efficacy study.
The European Medicines Agency’s (EMA) PRIority Medicines (PRIME) program recently reviewed Idefirix® due to its potential to provide a major therapeutic advantage over existing treatments, or benefit patients without treatment options. As such, Hansa is dedicated to ensuring the safety and efficacy of its innovative drug.
In August 2020, the European Commission granted Idefirix® conditional European Marketing Authorization for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
As the available kidney allocation system often fails to prioritize these highly sensitized patients, the conditional approval of Idefirix® allows for their immediate access to the medicine, even if all the data are not yet available.
About kidney failure
End-Stage Renal Disease (ESRD) is a devastating condition affecting nearly 2.5 million people worldwide. For those who are suitable for a transplant, it offers increased survival rates, improved quality of life, and is more cost-effective than long-term dialysis.
Unfortunately, across the European Union there are currently 80,000 individuals on the transplant waiting list. But with an organ transplant, those living with ESRD can look forward to a healthier future.
About Hansa Biopharma
Hansa Biopharma is a pioneering biopharmaceutical company on a mission to revolutionize the treatment of rare immunological conditions.
With their first-in-class IgG antibody-cleaving enzyme therapy, they are enabling kidney transplantation in highly sensitized patients and expanding their research and development program to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy, and cancer.
With operations in Europe and the US and a listing on Nasdaq Stockholm under the ticker HNSA, Hansa Biopharma has the potential to revolutionize patient care and make a lasting impact on the lives of those with rare immunological conditions.