Ampligen Earns Orphan Drug Designation for Ebola

In the United States, Orphan Drug designation is granted to drugs or biologics intended to treat, prevent, or diagnose a rare disease or condition. Rare conditions are those affecting fewer than 200,000 Americans. As a benefit, drug developers earn fee waivers, tax credits, increased regulatory assistance, and seven years of market exclusivity upon drug approval. This program was designed to help drive drug development in rare disease. According to a news release from immuno-pharma company AIM ImmunoTech Inc. (“AIM”), its candidate Ampligen (rintatolimod) recently earned Orphan Drug designation for Ebola virus disease (commonly referred to as Ebola). 

Ampligen is an investigational antiviral, immune-modulating therapy. Outside of Ebola, it is also being explored as a potential therapeutic option for various cancer subtypes, HIV, and chronic fatigue syndrome. VeryWellHealth shares some interesting insights on Ampligen and its effects on chronic fatigue syndrome. 

Prior studies in animals have shown that Ampligen was effective in reducing symptoms and stopping viral replication in illnesses like Ebola, severe acute respiratory syndrome coronavirus 1, and vaccinia virus infection. Moving forward, more research is planned to evaluate the efficacy and safety of Ampligen on reducing viral replication in patients with cancer who have also contracted COVID-19. 

What is Ebola?

Ebola Virus Disease (EVD), also known as Ebola hemorrhagic fever or simply Ebola, is a rare and sometimes fatal viral disease which can affect humans and primates. It is spread through infection with viruses within the Ebolavirus genus, including Ebola virus, Sudan virus, and Bundibugyo virus (among others). These viruses can be spread through contact with blood, tissue, or bodily fluid from an infected human or animal, or through sexual contact. Ebola outbreaks often occur on the African content. Symptoms may manifest anywhere from 2-21 days following infection, though onset typically occurs between 8-10 days. These can include:

  • Fever
  • Fatigue and general malaise
  • General weakness and body achies
  • Diarrhea
  • Nausea and vomiting 
  • Stomach pain
  • Sore throat
  • Appetite loss
  • Eye redness
  • Skin rashes
  • Unexplained hemorrhaging, bleeding, and bruising 

Recovery depends on good clinical care, treatment, and immune response. Treatment is necessary to avoid fatality.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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