Replies to post #158675 on Biotech Values

[ghmm]

There is actually quite a number of interesting opinions. A Bosentan (Tracleer) generic also received a positive nod. I think its 50/50 Actelions follow-on gets the nod even if it does I bet it only does a fraction of what Tracleer did.

[ariadndndough]

ARIAD Announces That Iclusig™ (Ponatinib) Receives Positive CHMP Opinion for Approval in the European Union
Press Release: ARIAD Pharmaceuticals, Inc. – CAMBRIDGE, Mass. & LAUSANNE, Switzerland--(BUSINESS WIRE)--

ARIAD Pharmaceuticals, Inc. (ARIA) today announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for Iclusig™ (ponatinib) for two indications:

•The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
•The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
“The positive recommendation by the CHMP of Iclusig for use in CML and Ph+ALL provides a broad indication statement for Iclusig in resistant and intolerant patients with Philadelphia positive leukaemias, including many patients who have failed only one prior tyrosine kinase inhibitor,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “We appreciate the substantial efforts of the CHMP in reaching this positive opinion so rapidly as a consequence of Iclusig’s accelerated assessment designation, and we look forward to the anticipated marketing authorization by the European Commission around mid-2013.”

Although Iclusig was studied in Ph+ ALL patients who were resistant or intolerant to dasatinib or nilotinib, nilotinib is not approved for the treatment of Ph+ ALL.

The CHMP granted ARIAD accelerated assessment for its review of the Iclusig marketing authorization application last summer. Accelerated assessment was introduced by the European Union in 2005. Its aim is to help speed access for patients to new medicines of major public-health interest. Companies can request accelerated assessment provided they are able to demonstrate that their product responds to an unmet medical need and is expected to have a major impact on medical practice.

The CHMP is a scientific committee composed of representatives from the 27-member states of the European Union (EU), and Iceland and Norway. The CHMP reviews medical product applications on their scientific and clinical merit and provides advice to the European Commission, which has the authority to approve medicines for the European Union.

CML is a cancer of the white blood cells that is diagnosed in approximately 7,000 patients each year in Europe[1]. CML and Ph+ ALL patients treated with tyrosine kinase inhibitors (TKIs) can develop resistance or intolerance over time to these therapies. Iclusig is a targeted cancer medicine discovered and developed at ARIAD. It was designed by ARIAD scientists using ARIAD’s platform of computational chemistry and structure-based drug design to inhibit BCR-ABL, including drug-resistant mutants that arise during treatment. Iclusig is the only TKI that has received a positive opinion from the CHMP for an indication that includes CML and Ph+ ALL patients with the T315Imutation


© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
21 March 2013
EMA/CHMP/178415/2013
Committee for Medicinal Products for Human Use (CHMP)
Summary of opinion1 (initial authorisation)
Iclusig
Ponatinib
On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Iclusig 15 mg film-coated tablets intended for the treatment of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designated as an orphan medicinal product on 2 March 2010. The applicant for this medicinal product is ARIAD Pharma Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The active substance of Iclusig is ponatinib, a protein kinase inhibitor (L01XE14). It acts by inhibiting the BCR-ABL kinase.
The benefits with Iclusig are its cytogenetic and haematological response rates in patients with CML and Ph+ ALL including patients bearing T315I mutation. The most common side effects are platelet count decreased, rash, dry skin, and abdominal pain.
A pharmacovigilance plan for Iclusig will be implemented as part of the marketing authorisation.
The approved indication is: “Iclusig is indicated in adult patients with
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
It is proposed that Iclusig be initiated by physicians experienced in the diagnosis and treatment of patients with leukaemia.