FDA Grants Orphan Drug Designation to Onspira Therapeutics’ Investigational Interleukin-1 Receptor Antagonist for the Treatment of Bronchiolitis Obliterans

According to a story from Business Wire, the biopharmaceutical company Onspira Therapeutics recently announced that its investigational therapy OSP-101 was recently granted Orphan Drug designation by the US Food and Drug Administration (FDA). The designation was granted for the treatment of bronchiolitis obliterans. Onspira Therapeutics specializes in the development of new treatments for potentially life-threatening, rare pulmonary diseases.

About Bronchiolitis Obliterans

Bronchiolitis obliterans, also known as popcorn lung or constrictive bronchiolitis, is a disease in which the smallest portions of the airways in the lungs become blocked because of inflammation. This is a disease with a diverse array of potential causes, which can include transplant rejection, viral infections, exposure to a variety of toxic fumes, certain medications, Stevens-Johnson syndrome, and rheumatoid arthritis. In a small percentage of cases, the cause is unknown. Symptoms of bronchiolitis obliterans include fatigue, shortness of breath, dry cough and wheezing. Symptoms progressively worsen over a period of weeks or months. It may also take a few weeks for symptoms to appear after exposure to the causative agent. Treatment includes a limited number of inhaled drugs, but there is only limited evidence for their effectiveness; some patients may need a lung transplant, but even this is not entirely curative for everyone. To learn more about bronchiolitis obliterans, click here.

About Orphan Drug Designation

Orphan Drug designation is limited to medical products that are intended to treat rare diseases that affect less than 200,000 people in the US. To obtain this status, an experimental drug must either display to potential to meet a currently unmet medical need or offer potential advantages in safety and/or effectiveness over currently available treatments. Orphan Drug designation provides several benefits to the recipient company, such as the waiving of certain fees, tax breaks, and an extended seven year period of market exclusivity if the product obtains approval from the FDA.

An Urgent Medical Need

Bronchiolitis obliterans is the most common cause of death in recipients of lung transplants, and can occur at higher than normal rates in this population. Therefore, the need for new treatments for this severe disease is incredibly urgent so that these patients have a greater chance of long term survival after their operation.

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