Expert Interview
Discussing the potential for US FDA approval for Soliris (Eculizumab) in treating Refractory generalized myasthenia gravis before FDA decision expected Oct. 23, 2017
Ticker(s): ALXNA neurologist with experience in treating Myasthenia gravis or other neuromuscular diseases.
Please describe your clinical practice. How many patients with Myasthenia gravis do you currently treat?
Added By: c_adminCan you talk about the patient populations suffering from Myasthenia gravis. Does the onset happen only past 40-60 years old? Once damage to the Nicotinic receptors has occurred, is it reversible, or rather, are the treatment options viable only for preventing the worsening of the disease?
Added By: c_adminIn its other indications for treating paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, Eculizumab increases the risk for meningococcal infections by up to 2,000 times, and as such, Eculizumab is available only through a restricted program.
- From your experience, does this greatly impede patients access to this medication? Are there safer alternatives for myasthenia gravis?
- In your opinion is it a risk doctors and patients would be willing to take?
Eculizumab in the PNH indication costs around ~$400.000/year. How much do alternatives in treating Myasthenia gravis cost at the moment. What hurdles does the drug have to overcome regarding payor reimbursement?
Added By: c_adminPhase 3 participants achieved a Myasthenia Gravis Composite (MGC) p-value of 0.1026 at week 26, change from baseline at week 26 being 0.0406.
- What is your general opinion of the P3 data?
- If approved in the US, how likely would you be to switch patients off of existing first-line therapies based on this data?
On a scale of 1-10, 10 being very excited, how would you rate your level of excitement for this drug?
Added By: c_adminAre You Interested In These Questions?
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