One Step Closer To EU Approval…

Today’s Daily Dose lists the names of drugs that have been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The lone exception is Vanda’s antipsychotic medicine Fanaptum, for which the CHMP has rendered a negative opinion.

Read on…

AbbVie’s (ABBV) biologic drug Humira just got one step closer to approval for pediatric uveitis patients in Europe – with the European Committee for Medicinal Products for Human Use issuing a positive opinion for the drug.

Humira has been granted positive opinion for the treatment of chronic non-infectious anterior uveitis in pediatric patients from two years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

The European Medicines Agency’s final decision for this expanded label indication is anticipated by September.

Humira was approved by the European Medicines Agency for the treatment of non-infectious intermediate, posterior and panuveitis in adults in June 2016.

The drug is also approved for use in adults with moderate to severe active and progressive rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate to severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

Humira is AbbVie’s best selling drug, and it netted global sales of $16.08 billion in 2016, up 14.7% over 2015.

ABBV touched a new 52-week high of $75.04 on Friday before closing the day’s trading at $74.63, up 0.84%.

Lexicon Pharmaceuticals Inc.’s (LXRX) XERMELO has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use to treat carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

The…

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