Celgene drug effective, safe in psoriasis trial
EU OKS Novartis drug for gout
LOS ANGELES, March 3, (RTRS): Celgene Corp’s experimental drug apremilast proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for US regulatory approval in the second half of 2013.
Celgene said 59 percent of patients in the 844-patient trial achieved a 50 percent improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17 percent of placebo patients. A 75 percent improvement in symptoms was seen in 33 percent of the treatment group and 5 percent of the placebo group.
The Phase 3 trial is the first of two pivotal studies of the drug in patients with psoriasis, a disease in which itchy, painful skin plaques are thought to be caused by an inflammatory response initiated by the body’s immune system.
Apremilast is a pill that inhibits an enzyme known as phosphodiesterase 4, or PDE4, and acts to damp down inflammation.
Planned
Celgene said previously it planned to file for Food and Drug Administration approval of the drug as a treatment for psoriatic arthritis in the first quarter of this year.
Side effects were consistent with those seen in earlier trials of the drug, with the most common being diarrhea Enbrel and AbbVie Inc’s Humira, can make patients more susceptible to infection, Dr Langley said. Schizophrenia: Regulators on Thursday approved a once-monthly injectable form of Abilify, the blockbuster treatment for schizophrenia, which will be sold by Japanese drugmaker Otsuka and Danish drug group Lundbeck.
In July 2012, the Food and Drug Administration declined to approve the medicine, Abilify Maintena, citing deficiencies from an inspection of a thirdparty supplier of sterile water. Otsuka and Lundbeck resubmitted their marketing application soon afterward, after working with an alternative supplier.
About 1 percent of adults in the United States are believed to have schizophrenia, a disorder of thought processes that can involve hallucinations, delusions and poor emotional responsiveness.
The new formulation of Abilify is meant to provide long-term prevention of relapses from schizophrenia symptoms, particularly for patients who don’t faithfully take their anti-psychosis medicines.
But the medicine has a convenience disadvantage. It comes in a “cake” form, which must be diluted with sterile water for injection. That means it has to be given by a healthcare professional.
For a decade, Otsuka and BristolMyers Squibb had co-marketed the once-daily basic formulation of Abilify, which had global sales of $2.8 billion in 2012. Under an updated partnership agreement, Otsuka early this year began to take on complete marketing responsibility for basic Abilify, but BristolMyers will continue to manufacture the medicine and share in revenue from it. Gout: The European Commission has approved Novartis’ drug Ilaris for patients with an often painful form of inflammatory arthritis, the drugmaker said on Friday.
Novartis said the EU had approved the drug also known as ACZ885 for patients with acute gouty arthritis who could not tolerate other treatment options. In 2011, US health regulators rejected Ilaris for use in gout over concerns about side effects. Hips: Johnson & Johnson’s DePuy unit was well aware of defects in its all-metal hips when plaintiff Loren Kransky was implanted with one of the devices in 2007, lawyers for the 65-year-old man said in closing trial arguments.
The lawsuit filed by the retired Montana prison guard is the first to reach court out of more than 10,000 filed against J&J in the wake of its 2010 recall of the ASR artificial hips.