|Class||Name/Company||Approval Dates and Comments|
Centocor, Inc./ Janssen-Cilag International
The US FDA and European Commission (EMEA) received a Biologics License Application (BLA) and Marketing Authorization Application, respectively, in December 2007 for approval of this novel, fully-humanized monoclonal antibody for the treatment of chronic moderate-to-severe plaque psoriasis. In February 2008, the US FDA accepted the BLA.
Hoffmann La-Roche/ Chugai Pharma
The US FDA and EMEA received a BLA and Marketing Authorization Application, respectively, in November 2007 for approval of this humanized interleukin-6 receptor-inhibiting monoclonal antibody for the treatment of moderate-to-severe rheumatoid arthritis.
|Neurotoxin||Botulinum Toxin Type A|
Medicis Pharmaceutical Corp./ Ipsen Ltd.
The US FDA received a BLA in December 2007 to market this neuromuscular blocking agent for esthetic indications. In January 2008, the FDA ruled the BLA as incomplete. Medicis is working with the agency to address the deficiencies.
The National Institute for Health and Clinical Excellence (NICE) in the UK announced the development of comprehensive guidelines in December 2007 aimed at improving the quality of life (QoL) and treatment of atopic dermatitis (AD) in children from birth to 12 years of age. Children’s needs and preferences, along with those of their healthcare providers, parents, and caregivers, are all factors that should be considered when dispensing best practice advice and making decisions regarding management and therapy. Furthermore, attention should be accorded to cultural considerations, and encouraging program access to those with disabilities or those who encounter language barriers. Key guideline recommendations include: avoidance of a uniform approach in disease assessment by considering individual QoL (i.e., daily activities, sleep and psychosocial wellbeing); adoption of a stepped approach for management by tailoring treatment steps to disease severity; healthcare providers will devote time to educating patients, parents, and caregivers about AD and its treatment; and clinical assessment will involve identification of potential triggering factors. It is estimated that 80% of AD cases seen by general practitioners are for mild forms of this skin condition. The intent of implementing these new guidelines is to substantially reduce unnecessary referrals for more specialized services by providing primary care physicians and affected individuals with an evidence based and supportive approach to successfully managing children with AD. The complete guidance report may be found at: http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11901.
|US FDA Alert|
The US FDA issued an alert in December 2007 regarding the link between severe or possibly fatal skin reactions following the use of carbamazepine by patients with Asian ancestry. Carbamazepine (Carbatrol®, Shire; Equetro®, Validus; Tegretol®, Novartis; and generics) is an anti-seizure medication used for the treatment of bipolar disorder, epilepsy and neuropathic pain. The life-threatening cutaneous reactions include Stevens-Johnson syndrome (e.g., rash, blistering and inflammation of the mucous membranes) and toxic epidermal necrolysis. These severe adverse reactions, though rare, are significantly more common in this segment of the population due to the presence of a specific human leukocyte antigen (GLA) allele, HLA-B*1502. Although the gene occurs almost exclusively in those with an Asian ancestry, all patients should undergo a blood test for risk assessment prior to start of therapy. Patients treated for several months with carbamazepine and exhibit no symptoms, even with the HLA-B*1502 marker, are at low risk for ever developing the side-effects. Of the treatment population affected, it is estimated that 5% are of Asian descent. The products’ labeling will be required to carry the new safety information in the boxed warning section.