FDA Grants Orphan Drug Designation to ONCOFID®-P

The FDA has recently granted ONCOFID®-P the Orphan Drug designation for the treatment of malignant mesothelioma (MM). This designation is reserved for therapies indicated for rare diseases, and it provides various benefits to the parent company. In this case, Fidia Farmaceutici will receive market exclusivity and other financial incentives based on preclinical data that demonstrates ONCOFID®-P’s high anti-tumor activity.


ONCOFID®-P is an anti-cancer drug that is made of hyaluronic acid (HA) and paclitaxel (taxol). Based on preclinical data, it is able to provide MM patients with a number of advantages, such as loco-regional administration.

This drug binds to malignant cells that express CD44, and its muco-adhesive property concentrates it to the cancerous tissue. Because of this, there is minimal systemic diffusion. Further preclinical studies are planned, and Fidia plans to apply for authorization for human trials by 2022.

These steps in development are very exciting for patients and doctors alike, as they may lead to another treatment option for MM. Currently, this rare and aggressive cancer faces a high mortality rate. According to Professor at the University of Padua and Director of the Immunology and Molecular Oncology Diagnostics Unit and Deputy Scientific Director at the Istituto Oncologico Veneto IRCCS, Professor Antonio Rosato,

Oncofid-P represents a very important step forward for the treatment of this serious disease”

About Mesothelioma

Mesothelioma is a rare and aggressive form of cancer that is the result of exposure to asbestos. There are two different forms, distinguished by where in the body the cancer begins to grow. Pleural mesothelioma impacts the tissue that surrounds the lungs while peritoneal/pericardial mesothelioma affects the tissue around the abdomen, heart, and testicles. Symptoms include:

  • Pain under the rib cage
  • Trouble breathing
  • Unintentional weight loss
  • Anemia
  • A buildup of fluid in the abdomen or lungs
  • Pain, swelling, or lumps in the abdomen

In terms of treatment, there is currently no cure. Treatment options consist of chemotherapy, surgery to remove tumors, radiation therapy, and targeted therapy.

Find the source article here.

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