Actemra: FDA Advisory Committee Recommends Approval of Roche's Arthritis Drug

[Guest guest]

FDA Advisory Committee Recommends Approval of Roche's Arthritis Drug

www.redorbit.com/news/health/1503481/fda_advisory_committee_recommends_approval_\

of_roches_arthritis_drug/#

Roche has announced that the arthritis advisory committee of the FDA has

recommended approval of Actemra, a novel interleukin-6 receptor-inhibiting

monoclonal antibody, for reducing the signs and symptoms in adults with

moderate to severe rheumatoid arthritis.

The committee's vote was made after Roche presented results from five Phase

III clinical trials. The clinical development program was designed to

evaluate the effects of Actemra on signs and symptoms of rheumatoid

arthritis (RA), physical function, progression of structural damage, and

health-related quality of life.

Of these five studies, three trials were conducted in patients with

inadequate response to disease modifying anti-rheumatic drugs (DMARDs), one

trial was conducted in patients who failed anti-tumor necrosis factor

therapy, and one monotherapy study comparing Actemra to methotrexate, a

current standard of care, was also conducted.

Results of these studies have demonstrated that treatment with Actemra -

alone or in combination with methotrexate or other DMARDs - significantly

reduced RA signs and symptoms, regardless of previous therapy or disease

severity, compared with current DMARDs.

Bahrt, global medical director of autoimmunity for Roche, said:

" Based on the strength of the data presented, and the positive

recommendation by the committee, we are hopeful that the FDA will approve

Actemra for the treatment of RA and provide a new option to patients who are

not achieving adequate symptom relief with current therapies. "

[Guest guest]

Does anyone know how long this process may take before Actemra

becomes available?

>

> FDA Advisory Committee Recommends Approval of Roche's Arthritis Drug

>

www.redorbit.com/news/health/1503481/fda_advisory_committee_recommends

_approval_of_roches_arthritis_drug/#

> Roche has announced that the arthritis advisory committee of the

FDA has

> recommended approval of Actemra, a novel interleukin-6 receptor-

inhibiting

> monoclonal antibody, for reducing the signs and symptoms in adults

with

> moderate to severe rheumatoid arthritis.

>

> The committee's vote was made after Roche presented results from

five Phase

> III clinical trials. The clinical development program was designed

to

> evaluate the effects of Actemra on signs and symptoms of rheumatoid

> arthritis (RA), physical function, progression of structural

damage, and

> health-related quality of life.

>

> Of these five studies, three trials were conducted in patients with

> inadequate response to disease modifying anti-rheumatic drugs

(DMARDs), one

> trial was conducted in patients who failed anti-tumor necrosis

factor

> therapy, and one monotherapy study comparing Actemra to

methotrexate, a

> current standard of care, was also conducted.

>

> Results of these studies have demonstrated that treatment with

Actemra -

> alone or in combination with methotrexate or other DMARDs -

significantly

> reduced RA signs and symptoms, regardless of previous therapy or

disease

> severity, compared with current DMARDs.

>

> Bahrt, global medical director of autoimmunity for Roche,

said:

> " Based on the strength of the data presented, and the positive

> recommendation by the committee, we are hopeful that the FDA will

approve

> Actemra for the treatment of RA and provide a new option to

patients who are

> not achieving adequate symptom relief with current therapies. "

>

[Guest guest]

If you go to www.clinicaltrials.gov and search Juvenile rheumatoid

arthritis, you will find the trials that are just now starting for

systemic jra. The drug is actually called Tociluzumab (that may be

misspelled).

> >

> > FDA Advisory Committee Recommends Approval of Roche's Arthritis

Drug

> >

>

www.redorbit.com/news/health/1503481/fda_advisory_committee_recommends

> _approval_of_roches_arthritis_drug/#

> > Roche has announced that the arthritis advisory committee of the

> FDA has

> > recommended approval of Actemra, a novel interleukin-6 receptor-

> inhibiting

> > monoclonal antibody, for reducing the signs and symptoms in

adults

> with

> > moderate to severe rheumatoid arthritis.

> >

> > The committee's vote was made after Roche presented results from

> five Phase

> > III clinical trials. The clinical development program was

designed

> to

> > evaluate the effects of Actemra on signs and symptoms of

rheumatoid

> > arthritis (RA), physical function, progression of structural

> damage, and

> > health-related quality of life.

> >

> > Of these five studies, three trials were conducted in patients

with

> > inadequate response to disease modifying anti-rheumatic drugs

> (DMARDs), one

> > trial was conducted in patients who failed anti-tumor necrosis

> factor

> > therapy, and one monotherapy study comparing Actemra to

> methotrexate, a

> > current standard of care, was also conducted.

> >

> > Results of these studies have demonstrated that treatment with

> Actemra -

> > alone or in combination with methotrexate or other DMARDs -

> significantly

> > reduced RA signs and symptoms, regardless of previous therapy or

> disease

> > severity, compared with current DMARDs.

> >

> > Bahrt, global medical director of autoimmunity for Roche,

> said:

> > " Based on the strength of the data presented, and the positive

> > recommendation by the committee, we are hopeful that the FDA will

> approve

> > Actemra for the treatment of RA and provide a new option to

> patients who are

> > not achieving adequate symptom relief with current therapies. "

> >

>