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jfm1330 ¼g¹D¡G ³o¸Ì¬O¤@­Ó¦nªº¤ñ¸û²£«~µû¦ô Ibalizumab ªº¼f§å®É­­¡C¹³ Ibalizumab ªº³æ§J¶©§ÜÅé¡C

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www.stockhouse.com/companies/bullboard/t.th/theratechnologies-inc?postid=26427871

jfm1330 wrote: Here is a good comparative product to assess timelines for approval for Ibalizumab. A monoclonal antibody like Ibalizumab.

The BLA was submitted on June 29, 2015

Given Priority review on September 1, 2015

PDUFA goal for approval February 29, 2016

FDA review completion November 13, 2015

FDA approval, November 30, 2015

So Priority Review came two months after submission of the BLA and approval five months after.

The BLA submission was under rolling review granted in May 2015

The phase III trial key for approval was conducted on 646 patients. So it¡¦s a trial that was 15 times larger than the phase III of Ibalizumab. Also there was about 250 patients in previous phase Ib/II trials These trials were also much longer and complicated than those of Ibalizumab (see link #1). So much more data to review by the FDA.

So if it took five months from initial BLA completed submission to approval for such a drug with large complicated trials aiming at a condition with other treatment alternative, it is logic to think that Ibalizumab process could be faster. Let¡¦s say four months instead of five. That would mean approval in early September.

www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761035Orig1s000MedR.pdf

www.drugs.com/history/empliciti.html

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Priority review is a mechanism used by the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for use of priority review to a drug developer as an incentive to develop treatments for neglected diseases and rare pediatric diseases. The voucher can be used for future drugs that could have wider indications for use, but the company is required to pay a fee (approximately $2.7 million) to use the voucher.

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FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

Biologics License Application (BLA) Accepted for Review with a Target Action Date of January 3, 2018

Ibalizumab Expanded Access Program (EAP) Currently Enrolling New Patients

Montreal, Canada ¡V June 30, 2017 ¡V Theratechnologies Inc. (Theratechnologies) (TSX: TH) today announced that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.

We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition, said Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc. ¡§The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition,¡¨ added Mr. Tanguay.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2018, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.

The BLA, submitted on May 3, 2017, is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease.

The ibalizumab Expanded Access Program (EAP), or study TMB-311, is ongoing and enrolling patients. For more information about TMB-311 (NCT02707861), please refer to the ClinicalTrials.gov website (www.clinicaltrials.gov) or the study website (www.ibalizumab-eap.com).

As HIV multiplies in the body, the virus may mutate to produce drug-resistant strains. Viral mutations may mean that HIV medicines that previously controlled a person¡¦s virus are no longer effective, causing treatment to fail. There are approximately 20,000 to 25,000 Americans with HIV-1 that are resistant to at least one drug out of the three different classes of antiretroviral therapies. Up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.

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{.....We reviewed TaiMed¡¦s most recent presentation and carefully assessed the market opportunity for ibalizumab.

Besides the MDR HIV-1 indication, we believe there is great potential for ibalizumab to be used off-label to treat patients who were non-adherent to conventional HIV treatments. As well, there are HIV-1 patients who are intolerant to current antiretroviral treatments (ART), says analyst Andre Uddin.....}

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