Innovative Medicine designation for Zepzelca from UK's MHRA

Spanish drugmaker PharmaMar (MC: PHM) has announced that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. The ILAP comprises as the first step an “Innovation Passport” designation which supports innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The criteria for the innovation passport include where the condition is life-threatening or seriously debilitating, or where there is a significant patient or public health need and where the medicinal product has the potential to offer benefits to patients (improved efficacy or safety, improved patient care or quality of life as compared to alternative therapeutic options).

De Ali Zeaiter, vice president clinical development and regulatory affairs of PharmaMar, said: “Lurbinectedin is an innovative medicine that showed clinical benefit for patients with relapsed small cell lung cancer (SCLC) and obtained provisional approvals in a number of countries (including USA, Canada and Australia) and is being developed in other clinically significant indications. SCLC represents an unmet medical need in the UK and worldwide, and our objectives are aligned with those of the UK public health authorities to facilitate and improve patients access to medicines such as lurbinectedin,” and added: “We believe that the innovation passport designation is an important step towards facilitating SCLC patients’ access to a new treatment option.”