History in multiple sclerosis
In the mid-1990s, Beutler, in collaboration with Jack Sipe, a neurologist at Scripps Institute, ran several clinical trials exploring the utility of cladribine in multiple sclerosis, based on the drugs immunosuppressive effects. Sipes insight into multiple sclerosis, and Beutlers interest in multiple sclerosis due to his sister having the disease, initiated a very productive collaboration. Ortho-Clinical, a subsidiary of Johnson & Johnson, filed a new drug application for cladribine for multiple sclerosis in 1997 but withdrew it in the late 1990s after discussion with the FDA proved that more clinical data would be needed.Ivax acquired the rights for oral administration of cladribine to treat multiple sclerosis from Scripps in 2000, and partnered with Serono in 2002. Ivax was acquired by Teva in 2006, and Merck KGaA acquired control of Seronos drug business in 2006.An oral formulation of the drug with cyclodextrin was developed: 16  by Ivax and Serono, and then Merck KGaA conducted clinical trials. Merck KGaA submitted an application to the European Medicines Agency in 2009, which was rejected in 2010, and an appeal was denied in 2011.: 4–5   Likewise Merck KGaAs new drug application with the FDA rejected in 2011.The ratio of benefit to harm was not clear to regulators, and further studies were requested to address concerns related to severe lymphopenia and cancer cases observed during pivotal trials. : 54–55  Clinical studies of multiple sclerosis were still ongoing at the time of the rejections, and Merck KGaA committed to completing them.
As is the case with all pervasive developmental disorder categories, there is considerable controversy about the right treatment for CDD. Signs and symptoms
CDD is a rare condition, with only 1.7 cases per 100,000.A child affected with childhood disintegrative disorder shows normal development. Up until this point, the child has developed normally in the areas of language skills, social skills, comprehension skills, and has maintained those skills for about two years. However, between the ages of two and 10, skills acquired are lost almost completely in at least two of the following six functional areas:
Expressive language skills (being able to produce speech and communicate a message)
Receptive language skills (comprehension of language – listening and understanding what is communicated)
Social skills and self care skills
Control over bowel and bladder
Play skills
Motor skillsLack of normal function or impairment also occurs in at least two of the following three areas:
Social interaction
Communication
Repetitive behavior and interest patternsIn her book, Thinking in Pictures, Temple Grandin argues that compared to "Kanners classic autism" and to Asperger syndrome, CDD is characterized with more severe sensory processing disorder but less severe cognitive problems. She also argues that compared to most autistic individuals, persons with CDD have more severe speech pathology and they usually do not respond well to stimulants. Causes
All of the causes of childhood disintegrative disorder are still unknown. Sometimes CDD surfaces abruptly within days or weeks, while in other cases it develops over a longer period of time.