Asthma treatment principles

The peptide leukotrienes 99,100, and 101 cause contraction of the bronchial smooth muscle and probably play an important role as mediators in allergic reactions (e.g. asthma) and inflammations. Antagonistic blockade of the leukotriene action of 99,100, and 101, by analogy with histamine Hj-reccptor antagonists, would therefore be an important principle in the treatment of allergic symptoms. A number of selective peptide leukotriene antagonists have in fact been synthesized by Smith Kline ... 

It is obvious that arthritis, epilepsy, depression, asthma and other similar diseases are not rare and drugs to treat them do not qualify for orphan drug designation. But would a medically plausible subset of each disease qualify as an orphan indication if there were fewer than 200 000 patients with, for example, a severe form of the disease The FDA s principle in addressing this common question is to ask the question Could (and would) patients with less severe forms of the disease use the new treatment If so, then the FDA says that the indication is not a true orphan and usually denies the application for orphan designation. 

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