Abbott pulls briakinumab filings in the US and EU
This article was originally published in Scrip
Abbott is looking at a possible several-year delay for its new Crohn's disease therapy briakinumab, after withdrawing its approval applications for the product in both the US and the EU.
In a 14 January SEC filing, the company said it took the step "following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies". It added that it was evaluating its next steps for the product, including resubmission at a later date.
Briakinumab is a fully human anti-IL-12/IL-23 inhibitor, similar to Centocor's (Johnson & Johnson) Stelara (ustekinumab), which was approved in the US and EU last year for moderate to severe plaque psoriasis.
Abbott appears to be pitching briakinumab as a niche product to complement its multi-billion dollar anti-TNF Crohn's treatment Humira (adalimumab). "While anti-TNFs are the cornerstone of biologic treatment for psoriasis, these data suggest that briakinumab may be evaluated as a potentially important alternative treatment option for some psoriasis patients," said Dr Eugene Sun, vice-president of global pharmaceutical development, when the company released the drug's first Phase III data in October. And just last week, briakinumab was not among those new product candidates highlighted by CFO Thomas Freyman at Abbott's presentation at the JP Morgan conference. Nevertheless, analysts have suggested peak sales of the product at around the $800 million mark.
The EMA said briakinumab (100mg solution for injection) was filed (as Ozespa) last September for moderate to severe chronic plaque psoriasis in adults who failed to respond to, or who have a contraindication to or are intolerant of, other systemic therapies, including ciclosporin, methotrexate and PUVA. The agency will release more information on the state of the scientific assessment for briakinumab at the time of the application's withdrawal after this week's CHMP meeting (due to end on 20 January).
Abbott presented data from four pivotal studies at the October European Association of Dermatology and Venereology meeting in Gothenburg, Sweden, showing that significantly more patients receiving briakinumab achieved 75% or better clearance rates based on PASI (psoriasis area and severity index) than those receiving the anti-TNF agent etanercept (Amgen/Pfizer's Enbrel), methotrexate or placebo.
The most common side-effects for briakinumab across the four studies were upper respiratory infection, nasopharyngitis, headache, arthralgia, hypertension and back pain. The incidences of infection and malignancy were higher with briakinumab than placebo but were similar to those in patients receiving methotrexate or etanercept.
An increase in major adverse cardiac events was seen in one placebo-controlled study although Abbott noted that all affected patients had identifiable underlying cardiovascular risk factors.