NEW BRUNSWICK (dpa-AFX) - The FDA is scheduled to organize Rare Disease Day,
a virtual public meeting, on March 1, 2024, as part of the global Rare Disease
Week.

In the U.S., as per the parameters outlined by the 1983 Orphan Drug Act, a
condition is classified as a rare disease if it affects fewer than 200,000
individuals. In the European Union, as per the legislation instituted in the
year 2000, a disease is considered rare when it affects fewer than 1 in 2,000
people.

It is estimated that there are more than 10,000 rare diseases and only a small
percentage, around 5% or less, have at least one approved treatment.

Every year, the last day of February is observed as Rare Disease Day, and this
year, it falls on Feb.29.

Shifting gears to recent developments on the regulatory landscape, notable
milestones have been achieved in February.

Eicos Sciences' Aurlumyn injection secured the FDA nod on Feb.14, 2024, becoming
the first medication to treat severe frostbite in adults to reduce the risk of
finger or toe amputation.

Novartis/Roche's Xolair was granted approval on Feb.16, 2024, becoming the first
medication to help reduce allergic reactions to multiple foods after accidental
exposure. The drug is already approved in the treatment of asthma, chronic
rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

Now, let's take a look at the biotech stocks awaiting FDA decision in March
2024.



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