Ab­b­Vie is ap­proach­ing the FDA with a new ther­a­py to po­ten­tial­ly treat Parkin­son’s dis­ease, us­ing pro­drugs of two med­ica­tions com­mon­ly used for the con­di­tion.

The Big Phar­ma sub­mit­ted its NDA for AB­BV-951, a so­lu­tion of lev­odopa and car­bidopa pro­drugs be­ing eval­u­at­ed in ad­vanced Parkin­son’s pa­tients who don’t re­spond well to oral ther­a­py, Ab­b­Vie an­nounced Fri­day morn­ing. Re­searchers are hop­ing a pos­i­tive Phase III study that reads out in late Oc­to­ber will help move things along quick­ly at the agency.

Ab­b­Vie’s the­o­ry here re­volves around the use of a con­tin­u­ous, 24-hour in­fu­sion of its ther­a­py as a unique and ef­fec­tive way to treat ad­vanced Parkin­son’s dis­ease. The lev­odopa and car­bidopa pro­drugs are de­liv­ered in small dos­es sub­cu­ta­neous­ly through a pump, and they’re de­signed to ac­ti­vate once they en­ter the blood­stream.

Much of Ab­b­Vie’s re­search thus far has cen­tered around find­ing the right con­cen­tra­tion to be able to de­liv­er the low­er lev­odopa and car­bidopa dos­es while still in­duc­ing ef­fi­ca­cious re­spons­es. Oral lev­odopa in par­tic­u­lar is one of the most com­mon­ly pre­scribed Parkin­son’s drugs, but its ef­fect wanes quick­ly and can fail to con­trol mo­tor symp­toms if the nar­row ther­a­peu­tic win­dow is missed.

In its piv­otal Phase III study, Ab­b­Vie asked pa­tients to self-re­port the times when they felt their symp­toms were well-con­trolled and when they weren’t in a spe­cial­ized di­ary. The com­pa­ny de­scribed these as “On” and “Off” times, re­spec­tive­ly. Ab­b­Vie’s pri­ma­ry end­point aimed to mea­sure the change in base­line “On” time in hours with­out in­vol­un­tary move­ments af­ter 12 weeks.

Af­ter that time, the av­er­age in­crease was 2.72 hours of “On” time for pa­tients tak­ing AB­BV-951 and 0.97 among those on stan­dard of care. Ad­di­tion­al­ly, de­creas­es of “Off” time came in at 2.75 hours in the treat­ment arm and 0.96 hours in the stan­dard of care group.

Both dif­fer­ences were sta­tis­ti­cal­ly sig­nif­i­cant, clock­ing in at re­spec­tive p-val­ues of p= 0.0083 and p=0.0054.

Ab­b­Vie has yet to pro­vide a full break­down of da­ta at a med­ical con­fer­ence, but the com­pa­ny not­ed the ad­verse event pro­file came in large­ly mild-to-mod­er­ate. Most side ef­fects had to do with the in­fu­sion site, in­clud­ing pain, red­den­ing of the skin, in­flam­ma­tion and bruis­ing. Though most were non-se­vere, a much high­er rate of pa­tients in the treat­ment arm (21.6%) dis­con­tin­ued in the study than those tak­ing stan­dard of care (1.5%).

The com­pa­ny is hop­ing this Parkin­son’s pro­gram turns out bet­ter than one of its pre­vi­ous­ly part­nered can­di­dates. Last month, Ab­b­Vie dropped its col­lab­o­ra­tion with Swe­den’s BioArc­tic around a port­fo­lio of al­pha-synu­cle­in an­ti­bod­ies, in­clud­ing one pre­vi­ous­ly ex­pect­ed to be ready for Phase II.

Should Ab­b­Vie net ap­proval here, they’d beat a cou­ple Big Phar­ma com­peti­tors to the punch. Roche and Prothena are still in Phase III on a pro­gram part­nered for $600 mil­lion, while No­var­tis inked a $1.5 bil­lion pact to get its hands on two UCB as­sets — one small mol­e­cule in­hibitor and one an­ti­body.

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”