In a so-called complete response letter, the U.S. drug regulator asked the German conglomerate to either provide additional analyses of study results that it had already submitted, or carry out new trials.

June 26, 2009

A new electronic, multidose, autoinjection device improves subcutaneous delivery of interferon beta (IFNB)-1a in patients with relapsing multiple sclerosis (MS), according to a study presented here at the 19th Meeting of the European Neurological Society (ENS2009).

Virginia Devonshire, MD, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, presented the results of a multicenter, single-arm, open-label, phase 3b study on June 24.

“Patients have problems with their adherence and initiation of therapies because these are injectable therapies, so we were looking at whether patients would find this device more suitable for injection,” said Dr. Devonshire.

She also indicated that the device enables adjustable injection depth and speed, has a hidden needle, provides visual and audio cues during the injection process, and records an accurate dosing history.

The study evaluated the suitability of the device for subcutaneous (SC) administration of the 3-times-weekly (TIW) formulation of IFNB-1a 44 mcg, as well as the incidence of injection-site reactions (ISRs), patient satisfaction with use, and impressions of the characteristics of the device.

Enrolled patients (n = 106) had received IFNB-1a 44 mcg SC TIW consistently for >=6 weeks before screening.

Patients who received regular injection of any other medication during the screening and study periods were excluded, as were patients with any physical/visual impairment that would preclude proper use of the device.

At baseline, patients were trained in the use of the new device and received IFNB-1a 44 mcg SC TIW for 12 weeks. Assessments were performed at baseline and weeks 2, 4, 8, and 12.

A total of 101 patients completed the study.

At week 12, 71.6% of patients indicated that this new device was suitable or very suitable. Most patients gave the same ratings for the various individual functions of the device (80.8%-95.2%), with most (95.2%) also rating these as easy or very easy to use.

In addition, 58.7% of the patients rated the device more or much more convenient than their previous device, and 60.2% requested to continue using it.

“We think that this is a good advance, and there will certainly be a group of patients who will prefer to have this kind of autoinjector,” said Dr. Devonshire.

“The main hurdle with new patients is often getting them onto a therapy, so this may offer something for that patient who is fairly needle phobic or is worried about going onto a therapy by injection,” he concluded

View entire post here: http://multiplesclerosis.blogharbor.com/blog/_archives/2009/6/29/4239965.html

Oral cladribine (EMD Serono) reduced the relapse rate significantly more than inactive placebo in the phase 3 “CLARITY” study of 1,326 people with relapsing-remitting MS. These initial results – the first from any phase 3 study of oral therapy for MS — are reported in a press release from EMD Serono dated January 23, 2009. Additional study results will be submitted for presentation at an upcoming scientific meeting. Oral cladribine has been designated by the U.S. Food and Drug Administration as a “Fast Track Product,” which should expedite its future review. The company plans to file for FDA approval of oral cladribine in mid-2009.

Background: Cladribine can interfere with the activity of white blood cells that underlie the immune attacks that cause the unpredictable symptoms of MS. Injectable cladribine is used to treat hairy cell leukemia. Studies have suggested a benefit in MS. In addition to the completed CLARITY study, other ongoing studies of oral cladribine funded by EMD Serono include:
• The ONWARD study, an investigation of the safety and effectiveness of adding high or low doses of oral cladribine to interferons in a trial recruiting 260 people with relapsing forms of MS (this study is currently recruiting participants); and
• The ORACLE MS study, designed to evaluate the safety and effectiveness of oral cladribine in people who have experienced a neurological episode that puts them at risk for developing MS (this study is currently recruiting participants).

The CLARITY Study: For the first year of the study, 1,326 participants were randomly assigned to receive a low dose of cladribine (two treatment cycles per year, each cycle consisting of one tablet per day for four to five consecutive days), a high dose (four cycles) of cladribine, or inactive placebo. In the second year, both treatment groups received a low dose of cladribine. The primary endpoint was the drug’s effect on relapse rate at two years compared with placebo. Secondary endpoints included effects on disease activity, as detected by MRI scans, the proportion of relapse-free participants, and disability progression.

The relapse rate was reduced significantly more than placebo in both treatment groups (by 58% in the low-dose group and by 55% in the high-dose group). The company reports that secondary endpoints of the CLARITY study were also met, although the details of these are not provided in the press release. Additional study results will be submitted for presentation at an upcoming scientific meeting.

Lymphopenia – a reduction of white blood cells – was the most frequent adverse event, and occurred more frequently in the groups on cladribine. Other adverse events reported in all three groups were headaches and cold symptoms.

“These are exciting initial results, and we look forward to seeing the full data,” says John Richert, MD, Executive Vice President of Research and Clinical Programs at the National MS Society. “If this pill proves to be safe and effective for people with relapsing MS, it represents a major treatment breakthrough – hopefully the first of many more in the pipeline.”

View full post here: http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=650

Teva’s laquinimod for MS gets fast tracked
February 12, 2009 — 3:34pm ET | By Calisha Myers

Israel-based Teva Pharmaceutical announced today that the FDA has granted the Fast Track designation to laquinimod, its investigational treatment for relapsing-remitting multiple sclerosis (RRMS). Laquinimod is a once-daily treatment administered orally. Teva licensed the compound from Swedish developer Active Biotech in 2004.

The first phase III clinical trials–Allegro–were completed in November 2008 and Teva is now enrolling patients globally for Bravo, the second Phase III study. Teva said that with the FDA’s decision, the drug could enter the market as soon as late 2011. “We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies,” Moshe Manor, Vice President, Global Innovative Resources Group at Teva, said in a statement.

Shares of Teva rose 75 cents to $43.88 in afternoon trading on Thursday, while Active Biotech’s shares jumped $3.40 to $38.30.

ALSO: It seems that Teva is trying to make 2009 the year of generics. The company’s new campaign, “Year of Affordable Healthcare,” employs social media–including YouTube, Twitter and possibly Second Life– and various other tools to build its largest ever PR campaign. Teva tells PRWeek that 2009 is “a critical year for the future of both healthcare in America and the generic drug industry.” Report