5/31/2016
`
`Methotrexate | FDA Approves Rasuvo
`
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`FDA OKs a New Methotrexate Injection
`Device
`Rasuvo, a pre(cid:251)lled syringe, may make injection easier.
`| By Linda Rath
`
`The Food and Drug Administration (FDA) has approved an
`injectable form of methotrexate that is administered in a pre(cid:250)lled
`auto-injector; it’s the second such product approved in less than a
`year. The new product, called Rasuvo, is indicated for adults with
`severe rheumatoid arthritis (RA) or psoriasis, and for children with
`polyarticular juvenile idiopathic arthritis (pJIA).
`
`Methotrexate is one of the most commonly used treatments for
`in(cid:251)ammatory types of arthritis. A disease-modifying antirheumatic
`drug (DMARD), it can help slow joint destruction over time in
`addition to relieving pain. Methotrexate is commonly available as
`a pill or injection.
`
`Until recently, the injectable form had to be measured and drawn
`into a syringe from a multidose vial. But in October 2013, the FDA
`approved Otrexup, a pre(cid:250)lled, disposable auto-injector that
`delivers a single dose of methotrexate without the need for vials or
`measuring.
`
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`Rasuvo also delivers methotrexate in a pre(cid:250)lled auto-injector. It differs from Otrexup by offering more dosing options.
`Otrexup comes in four strengths: 10 milligrams (mg), 15 mg, 20 mg and 25 mg; Rasuvo is available in 10 strengths,
`ranging from 7.5 to 30 mg in 2.5 mg increments. (The starting dose for most adults is 7.5 to 10 mg; for children, the dose
`depends on weight).
`
`“For both Otrexup and Rasuvo, the clear bene(cid:250)t is that patients do not have to pull up the dose themselves and [the shot]
`is not painful,” says Natalie Azar, MD, a clinical assistant professor in the division of rheumatology at NYU Langone
`Medical Center in New York City.
`
`But Dr. Azar doesn’t see the extra dosing options as a big advantage. “Most patients will respond equally well to 15 mg
`and 17.5 mg, and the 5 mg dosing increments of Otrexup have been suf(cid:250)cient in my opinion,” she says.
`
`Mara Becker, MD, director of the division of rheumatology at Children’s Mercy Hospital in Kansas City, Mo., says the
`approval of Rasuvo is “great news” for kids with arthritis.
`
`“Subcutaneous [beneath the skin] administration of methotrexate is the preferred route in the 2011 American College of
`Rheumatology recommendations for the treatment of JIA. A [device] that can ease the administration of methotrexate is a
`great step forward for our patients and could minimize potential errors by having the appropriate dose pre(cid:250)lled in the
`syringe,” says Dr. Becker.
`
`Whether injections are better than pills for all patients is an ongoing debate. Some studies show injected methotrexate is
`better absorbed than the oral version, especially at doses greater than 15 mg, while other studies have found no
`signi(cid:250)cant difference between the two. There are also questions about whether the injected form reduces common side
`effects of oral methotrexate, such as nausea and vomiting. But self-injection can be dif(cid:250)cult – especially for kids and for
`adults with arthritic hands – and for many it is less appealing than swallowing a pill.
`
`http://www.arthritis.org/living-with-arthritis/treatments/medication/drug-types/disease-modifying-drugs/new-methotrexate-autoinjector.php#
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`Medac Exhibit 2070
`Frontier Therapeutics v. Medac
`IPR2016-00649
`Page 00001
`
`

`
`5/31/2016
`
`Methotrexate | FDA Approves Rasuvo
`
`Medac Pharma, which manufactures Rasuvo, says it has not yet set a price. Its competitor, Otrexup, costs $500 to $600
`a month for a 25 mg dose – more than a vial of methotrexate and far more than pills, which cost $20 to $30 for a dozen
`2.5 mg tablets.
`
`Dr. Azar says she hasn’t had trouble with insurance companies covering injectable methotrexate, but adds, “This will vary
`on a case-by-case basis given the patient’s insurance and prescription drug coverage.”
`
`According to a company representative, Rasuvo will be available the (cid:250)rst week of October.
`
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