Kladribiini (MOVECTRO) alkaa saada maailmalla viranomaishyväksyntöjä. Venäjä ja Australia pulkassa. Kyse on siis ensimmäisestä markkinoille tulevasta pillerimuotoisesta lääkkeestä MS:n hoitoon injisoitavien tilalle, jos ei jaksa kahlailla foorumia.

Sep 07, 2010 (Datamonitor via COMTEX) --
Merck Serono, a division of Merck KGaA, has reported that the Australian Therapeutic Goods Administration has approved cladribine tablets for the treatment of relapsing remitting multiple sclerosis, or MS.
Cladribine tablets will be registered in Australia under the trade name Movectro. This product, also under the trade name Movectro, became the first oral MS treatment in the world to gain marketing authorization when health authorities in Russia approved it in July 2010.

Jaha, nyt myös Fingolimodi on hyväksytty venäjällä. EMEA:llahan tämä on nyt arvioitavana.

Novartis International AG: Novartis announces Russian regulatory approval for Gilenya®, a once-daily oral multiple sclerosis therapy and first in a new class

Novartis International AG / Novartis announces Russian regulatory approval for Gilenya,
a once-daily oral multiple sclerosis therapy and first in a new class processed and
transmitted by Hugin AS. The issuer is solely responsible for the content of this
announcement.

* Russia is first country to approve Gilenya for the treatment of relapsing remitting
MS, the most common form of the disease

* Gilenya is the first disease-modifying treatment in a new drug class and offers
significant efficacy with a well-characterized safety tolerability profile

* Action from the US Food and Drug Administration (FDA) on Gilenya is expected in
September 2010; other submissions under review worldwide

Basel, September 10, 2010- The Russian health authority, the Federal Service on
Surveillance in Healthcare and Social Development, has granted approval for Gilenya
(fingolimod) 0.5 mg once-daily oral therapy for the treatment of relapsing remitting
multiple sclerosis (MS). Approximately 85% of patients with MS are estimated to have the
relapsing remitting form at the onset of disease[1]. Russia is the first country to
approve Gilenya, providing a new treatment option offering significant efficacy for
patients in the convenience of an oral capsule. Novartis expects to launch Gilenya in
Russia in early 2011.

In June, an advisory committee of the US Food and Drug Administration (FDA) unanimously
recommended approval of Gilenya and action from the FDA is expected in September 2010.
Gilenya is also under review by the European Medicines Agency (EMA) as well as other
health authorities worldwide.

Data from one of the largest-ever Phase III clinical trial programs conducted in MS were
submitted to support the regulatory submissions. These studies provided evidence of the
efficacy of Gilenya in reducing relapses, disability progression and brain lesions in
patients with relapsing remitting MS as well as safety data. Gilenya is the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators.
Gilenya provides selective and reversible retention of lymphocytes in lymph nodes,
preserving key immune functions and flexibility in patient management.

Jos lääke hyväksytään ensimmäiseksi Venäjällä, tulee melkein väkisinkin mieleen, että näinköhän lääkeyhtiö on hieman "sponsoroinut" tarvittavia tahoja...

Kas kun ei Somaliassa.

Mutta ei siinä mitään, hyvähän se on, että uusi lääke tulee saataville.

Kaikki ei aina mene niin kuin elokuvissa, rahakaan ei aina puhu omaa kieltään.

Kladribiini on saanut käsittelyssä kielteisen kannan EU:ssa, Merck joutuu puimaan asiaa lisää ja valittamaan lausunnosta. Ohessa alkuperäinen teksti.

----------------

Merck KGaA Announces CHMP Opinion for Cladribine Tablets in Multiple
Sclerosis

• Merck is committed to making Cladribine Tablets available to MS patients
in
Europe and is evaluating all options to gain approval in the European
Union

Darmstadt, September 24, 2010 – Merck KGaA announced today that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a negative opinion regarding the
marketing authorization application (MAA) for Cladribine Tablets as a
treatment for relapsing-remitting multiple sclerosis (MS). The CHMP is of
the opinion that based on currently available data the benefits of
Cladribine Tablets do not outweigh its risks. Merck is committed to making
Cladribine Tablets available to MS patients in Europe and is evaluating all
options to gain approval in the European Union, including a potential
appeal to request re-examination of the submission by the CHMP, in
accordance with the current European regulatory legislation.



The complete news release can be downloaded at the following link:
http://news.merck.de/N/0/FA052E789BBF2D4CC12577A800197C1E/$File/CladCHMPEn.pdf

Tietääkö kukaan mitä nuo mainitut kladribiinin "riskit" ovat?

Kiitos  

Tyhmä kysyy vielä, onko se siis solunsalpaaja? Tukka lähtee jne.

Tiedon murusia Gilenyasta.

Kladribiini on itse asiassa aika lailla vastatuulessa. EMA ei hyväksynyt ja seuraavat lupakierros on käsittääkseni 2012, kun ORACLE-tutkimuksen tulokset ovat käytettävissä. Syy kielteiseen päätökseen tässä vaiheessa oli se, että riskit ovat liian suuret hyötyihin nähden. FDA käsittelee kladribiinin ensi kuussa.

Täytyy muutama vuosi seurata miten porukka noita sietää ja tuleeko niistä mitä sivareita (syöpiä yms.). Sitten kun tulevat saataville. Sitten se varsinainen koe vasta alkaa, kun aletaan massoille noita syöttämään...

nimimerkillä,
i'm not gonna be the first on the line.