Plegridy Approved in EU!!! We need a new category!!!

[Marco]

Plegridy has been approved in the EU. Now waiting on the US FDA!!!

Chemically, Plegridy is similar to Avonex and Rebif, but it is only administered every 2 weeks. That means 26 injections per year!

[JerryD]

The next step will be FDA approval. Let me guess. This is another drug developed for the treatment of Relapsing Remitting MS. That will bring the number of drug therapies to 11. Primary and secondary progressive MS ... 0.

[BigA]

It's just long-acting Avonex. They had hoped to change weekly to monthly dosing, but it didn't cut it. I doubt I'll switch from Avonex.

[Marco]

US FDA approves Plegridy

Plegridy has now been approved in the US, roughly one month after the EU approved it. Plegridy sets a new standard for injection therapies with only 26 shots per year. Despite the reduction in injections the medication is expected to cost close to $5k/monthly for US patients.

Plegridy has the same active ingredient, interferon beta, as Biogen Idec’s first MS drug, Avonex, which is still being sold. But the company attached a polymer called polyethylene glycol, or peg, to Plegridy that increases the exposure of the drug, allowing patients to take doses less frequently. While Avonex has to be injected into the muscle once a week, Plegridy can be taken by injection every two weeks, administered under the skin with a prefilled auto-injector.

The drug will now go into production, marketing campaigns and will be available this fall. Insurance companies will have to add Plegridy to formulary plans, so expect delays with some insurance plans.

The oral medication market is still growing while the market share for injection therapies is shrinking. I would expect Plegridy to siphon users primarily from the existing injectables. Avonex and Rebif users should theoretically have the easiest time adjusting to Plegridy. For Betaseron and Extavia users the medication is still mostly a lateral transition.

[durgastiger]

APPROVED

Plegridy™ Approved for Relapsing Forms of MS

August 16, 2014
On August 15, 2014, Biogen Idec announced that the United States Food and Drug Administration (FDA) had approved Plegridy™ (peginterferon beta-1a) for the long-term treatment of relapsing forms of multiple sclerosis (MS). Manufactured by Biogen Idec, this new medication is the 11th disease-modifying therapy (DMT) to be approved for MS since the early 1990s. Plegridy is given once every two weeks through a subcutaneous self-injection.

More info is on the MSAA website.

[durgastiger]

Yeah disapointing .

My chiropractor is looking for a Dr. that will get LDN for me cheaper than FMP.