Products

Date: 2018-01-17

Type of information: Granting of the orphan status in the US

Product name: Otezla®

Compound: apremilast

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases - Rare diseases

Action mechanism:

• phosphodiesterase 4 inhibitor. Otezla® is an oral, small-molecule, selective inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. Otezla® was approved on September 23, 2014 by the FDA for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
• Otezla® is approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis.

Company: Celgene (USA - NJ)

Disease: pediatric patients with ulcerative colitis

Latest news:

• • On January 17, 2018, the FDA has granted orphan drug designation for Otezla® (apremilast)  for treatment of pediatric patients with ulcerative colitis.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2018-01-17

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes