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AbbVie secured marketing approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for ELAHERE

Following AbbVie's acquisition of marketing approval for ELAHERE from the MHRA, Med-Tech Insights sought clarification directly from the company.

AbbVie secures marketing approval from the MHRA for ELAHERE, paving the way for its launch in the...
AbbVie secures marketing approval from the MHRA for ELAHERE, paving the way for its launch in the UK market

AbbVie secured marketing approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for ELAHERE

In a significant development for the treatment of ovarian cancer, AbbVie's Mirvetuximab Soravtansine has been licensed as a monotherapy in the UK for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

The drug, which is intended to improve patients' quality of life compared with standard chemotherapy, is currently undergoing the submission process with both the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) for approval. AbbVie is working diligently to complete this process as efficiently as possible, recognising the importance of speedy access to Mirvetuximab Soravtansine for eligible women with the condition in the UK.

AbbVie's policy on pre-approval access is designed to protect the fair, equitable, and uninterrupted access of unapproved medications while also protecting the integrity of ongoing clinical trials.

The ongoing development program for Mirvetuximab Soravtansine includes evaluating it in combination with other therapies. Trials are underway to explore the use of Mirvetuximab Soravtansine in combination therapy for ovarian cancer in the second line plus platinum-sensitive and first-line maintenance settings.

It's worth noting that the reimbursement timing for drugs like Mirvetuximab Soravtansine depends on when NICE and SMC complete their appraisals and companies complete pricing and access negotiations. While a positive appraisal could potentially lead to the NHS making the drug available within months, the specific timing varies case by case. However, without updated search data, an exact timetable cannot be provided currently. For the most precise and current information, consulting NICE and SMC official websites or announcements directly would be advisable.

Lastly, a global patient access scheme is in place for Mirvetuximab Soravtansine, and individual patients must speak with their clinicians for further guidance.

  1. The ongoing clinical trials for Mirvetuximab Soravtansine are exploring its use in combination with other therapies, particularly for women with ovarian cancer in the second line plus platinum-sensitive and first-line maintenance settings.
  2. Science plays a crucial role in the development of Mirvetuximab Soravtansine, a potential treatment for ovarian cancer, as it is undergoing evaluation in various medical-conditions, including combination therapy.
  3. For women with ovarian cancer in the UK, health-and-wellness improvements might be achievable through AbbVie's Mirvetuximab Soravtansine, pending approval from NICE and the SMC, and its successful navigation through the reimbursement process for cancer drugs.

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